Epub 2014 Oct 1. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588496. Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Effect of Evolocumab or Ezetimibe Added to Moderate- or High-Intensity Statin Therapy on LDL-C Lowering in Patients With Hypercholesterolemia: The LAPLACE-2 Randomized Clinical Trial. Found inside – Page 131Similar lipid-lowering effects were seen in the DESCARTES trial, MENDEL-2, and RUTHERFORD-2 trials [7, 9, 25]. One meta- analysis showed that evolocumab may ... Robinson JG, Nedergaard BS, Rogers WJ, et al. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. 2012 Jul 7;380(9836):29-36. doi: 10.1016/S0140-6736(12)60771-5. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. For general information, Learn About Clinical Studies. August 2015. Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. JAMA. Information provided by (Responsible Party): The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. Amgen Inc. Treatment-emergent adverse events occurred in ten (63%) of 16 patients in the placebo group and 12 (36%) of 33 in the evolocumab group. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The long-term, open-label study, OSLER, allowed patients completing LAPLACE-TIMI 57, RUTHERFORD, GAUSS, MENDEL or YUKAWA to be randomized 2:1 to evolocumab plus standard-of-care Epub 2021 Apr 7. Clinical practice is allied with basic science to guide all those with an interest in stroke on the diagnosis and management of intracranial atherosclerosis. Know the facts: read this book! Found insideThis book provides a comprehensive summary of the latest developments in the field of the genomics of cardiac disease. doi: 10.12659/MSM.928784. Found inside – Page 538... Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Management of Familial Hypercholesterolemia: Current Status and Future Perspectives. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities (TESLA) Part B is a randomised, double-blind, placebo-controlled phase 3 trial, undertaken at 17 sites in ten countries in North America, Europe, Middle East, and South Africa. The TESLA study was a two-part phase 2/3 trial evaluating the PCSK9 inhibitor evolocumab in patients with homozygous familial hypercholesterolemia (LDL ≥130 mg/dL).  (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Found insideComprising contributions from leading lipidologists from around the world, this book presents the latest and most comprehensive knowledge on the different options for combination therapy of dyslipidemia and includes discussion of future ... U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. = Moderate disability requiring some help, but able to walk without assistance. Each treated patient will be followed and assessed for 3 months after randomization. 2015 Jan 24;385(9965):331-40. doi: 10.1016/S0140-6736(14)61399-4. Epub 2014 Oct 1. Circulation. Curr Atheroscler Rep. 2021 Jul 8;23(9):51. doi: 10.1007/s11883-021-00951-2. The Cholesterol Wars chronicles the controversy that swirled around the 'lipid hypothesis' of atherosclerosis for so many years. In fact, 'the lower the better' is the position of many clinicians. Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm. 2021 May;38(5):2159-2169. doi: 10.1007/s12325-021-01720-y. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial Lancet. This new volume teaches readers about current advances in the field, describing the use of induced pluripotent stem cells to model several diseases in vitro, and thus enabling us to study the cellular and molecular mechanisms involved in ... The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke, 18 Years to 85 Years   (Adult, Older Adult), Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States, 72205, Principal Investigator: Sushrut Dharmadhikari, MD, Sacramento, California, United States, 95816, Principal Investigator: Rajkamal Khangura, MD, California Pacific Medical Center & Mills Peninsula Medical Center, San Francisco, California, United States, 94107, Principal Investigator: Nobl Barazangi, MD, Thousand Oaks, California, United States, 91360, Torrance, California, United States, 90503, Principal Investigator: Jason Tarpley, MD, Boca Raton, Florida, United States, 33486, Contact: Margaret Scott, RN    561-955-5784, Principal Investigator: Brian Snelling, MD, Coral Gables, Florida, United States, 33146, Principal Investigator: Dileep Yavagal, MD, Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital), Delray Beach, Florida, United States, 33484, Contact: Gillian Robbins, RN    561-495-3145, Memorial Healthcare System - South Broward Hospital, Principal Investigator: Brijesh Mehta, MD, Principal Investigator: Marshall Cress, MD, Contact: Rebecca McConnell, BSN    770-434-6959, Chicago, Illinois, United States, 60612-7227, Principal Investigator: Sameer Ansari, MD, central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital, Principal Investigator: Dhruvil Pandya, MD, Contact: Heena Olalde, RN, MSN    319-356-8326. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Utility-weighted 90-day Modified Rankin Score [ Time Frame: 90 days post randomization ]. Listing a study does not mean it has been evaluated by the U.S. Federal Government. doi: 10.1210/jendso/bvaa122. In the TESLA part B trial (Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities), evolocumab demonstrated reductions in LDL-C of 30.9% compared with standard medical therapy.20 The GAUSS-2 trial (Goal Achievement after Utilising an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2 trial… Study record managers: refer to the Data Element Definitions if submitting registration or results information. Homozygous Familial Hypercholesterolemia (HoFH) in Saudi Arabia and Two Cases of Lomitapide Use in a Real-World Setting. Patients received evolocumab 420 mg subcutaneous once monthly for 12 weeks. Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks. Information provided by (Responsible Party): A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH). In the Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA) pilot study, eight HoFH patients with LDLR-negative or LDLR-defective mutations on stable drug therapy were treated with open-label SC evolocumab 420 mg Q4W for at least 12 weeks, followed by 420 mg Q2W for an additional 12 weeks . Lancet. Bethesda, MD 20894, Copyright Study record managers: refer to the Data Element Definitions if submitting registration or results information. Privacy, Help Found inside – Page 90[79] The Lipid Research Clinics Coronary Primary Prevention Trial results. ... of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA ... To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Raal FJ, Hovingh GK, Blom D, Santos RD, Harada-Shiba M, Bruckert E, Couture P, Soran H, Watts GF, Kurtz C, Honarpour N, Tang L, Kasichayanula S, Wasserman SM, Stein EA. The TESLA Part B trial randomised 33 patients to add evolocumab and 17 patients to add placebo to their lipid-lowering therapy. You have reached the maximum number of saved studies (100). Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Clipboard, Search History, and several other advanced features are temporarily unavailable. Accessibility Dyslipidaemia: Evolocumab lowers LDL cholesterol. Found inside – Page 672Table 2 Results from clinical trials on evolocumabdcont'd Clinical trial ... NCT0143988096 Subjects from phase 2 evolocumab trials 1 year 420 mg ... [PCSK9 inhibition--A new era in cholesterol treatment].  (Clinical Trial). Interpretation: Endocrinol Metab (Seoul). Lancet.2015;385:341-50. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Keywords provided by Dr. Osama O. Zaidat, Mercy Health Ohio: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Careers. 3 TESLA Trial Of Evolocumab (AMG 145) In Patients With Homozygous Familial Hypercholesterolemia (Amgen press release, 3/17/14) Amgen Announces Positive Top-Line Results From Phase 3 RUTHERFORD-2 Trial Of Evolocumab (AMG 145) In Patients With Heterozygous Familial Hypercholesterolemia (Amgen press release, 1/30/14) Adv Ther. Found inside – Page 247... the reduction of LDL-C induced by evolocumab treatment was comparable to those ... HoFH patients.47 The TESLA part B trial reported similar results, ... 2021 Jun 14;6:CD007574. Found inside – Page 130A 52week placebo-controlled trial of evolocumab in hyperlipidemia. ... of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): ... Found inside – Page iThis comprehensive reference book of coronary microcirculation broadly covers theoretical aspects, clinical cases and therapeutic considerations from an innovative perspective. Bookshelf To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Blom DJ, Hala T, Bolognese M. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study. Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. 8600 Rockville Pike Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. Press release. TESLA-B Trial23 • Randomized, double-blind, placebo-controlled, phase III trial – 50 patients, 12 years or older with homozygous FH who were on lipid-lowering therapy but not lipid apheresis – Randomized to either evolocumab 420 mg or placebo every 4 weeks for 12 weeks Why The Extra Indication For Evolocumab?23 Found insideThis book provides an overview of statin-associated muscle symptoms (SAMS) from clinical presentation to treatment and possible metabolic causes. 2020 Aug 21;5(1):bvaa122. TESLA was a two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C at an early age. Patients in the evolocumab group had a mean baseline LDL- C of 356 mg/dL; those in the placebo group had a mean baseline LDL-C of 336 mg/dL. Found inside – Page 906Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebocontrolled trial. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Role of PCSK9 Inhibitors in Patients with Familial Hypercholesterolemia. Lancet 2014;Oct 1:[Epub ahead of print]. Would you like email updates of new search results? Found inside – Page 52A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. ... PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a ... Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Epub 2014 Oct 1. FOIA Clin Pharmacokinet. 2014 Dec;11(12):687. doi: 10.1038/nrcardio.2014.169. Please remove one or more studies before adding more. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia, 12 Years to 80 Years   (Child, Adult, Older Adult), Johannesburg, Gauteng, South Africa, 2193, Observatory, Western Cape, South Africa, 7925, Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ], Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ], Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12 [ Time Frame: Baseline and Week 12 ], Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ], Part B: Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ], Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ], Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline and Week 12 ], Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12 [ Time Frame: Baseline and Weeks 6 and 12 ], Males and females ≥ 12 to ≤ 80 years of age, Diagnosis of homozygous familial hypercholesterolemia, Stable lipid-lowering therapies for at least 4 weeks, LDL or plasma apheresis within 8 weeks prior to randomization, New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%, Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of randomization, Planned cardiac surgery or revascularization. Amgen announced that the Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). Epub 2012 May 26. This newly revised third edition of Manual of Lipid Disorders is an important tool for reducing morbidity and mortality by diagnosing and treating lipid disorders. Lancet. This text provides a comprehensive and up-to-date review of modern cardiovascular risk management. It belongs to the 'In Clinical Practice' series, which incorporate multiple illustrations using novel and effective formats. Found inside – Page 438A 52-week placebo-controlled trial of evolocumab in hyperlipidemia. ... PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a ... Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. TESLA Trial Design TESLA ( T rial E valuating PC S K9 Antibody in Subjects with L DL Receptor A bnormalities) is a two-part Phase 2/3 trial designed to evaluate the safety, tolerability and efficacy of evolocumab. This collection provides detailed descriptions of both standard and advanced meta-analytic methods and their implementation in Stata. = No significant disability despite symptoms; able to carry out all usual duties and activities. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial. Nevertheless, their relevance and validity still needs to be proven. This issue of the European Respiratory Monograph describes the current status regarding end-points in all relevant areas of pulmonary medicine. ClinicalTrials.gov Identifier: NCT03805308, Interventional 2021 May 7;27:e928784. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. Conventional therapy is with statins, ezetimibe, and apheresis. Matta A, Bongard V, Bouisset F, Taraszkiewicz D, Rabès JP, Ferrières J. Med Sci Monit. Found inside – Page 2048 TABLE 13-1 Summary of Initial Randomized Clinical Trials for Thrombolytic ... A 52-week placebocontrolled trial of evolocumab in hyperlipidemia. Epub 2021 Apr 19. TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) is a two-part Phase 2/3 trial designed to evaluate the safety, tolerability and efficacy of evolocumab. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): A randomised, double-blind, placebo-controlled trial October 2014 The Lancet 385(9965) Lancet Diabetes Endocrinol. A second blinded statistician will be part of the steering committee. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU. Found inside – Page 204Summary of Initial Randomized Clinical Trials for Thrombolytic Therapy in ... A 52-week placebocontrolled trial of evolocumab in hyperlipidemia. 2017 Apr;5(4):280-290. doi: 10.1016/S2213-8587(17)30044-X. Two open-label trials enrolling patients who had completed 1 of 12 phase 2 (OSLER 1) or phase 3 (OSLER 2) evolocumab studies with the goal of gathering long-term data on safety and side effects of evolocumab and LDL-C reduction, as well as securing an exploratory analysis on adjudicated CVD events At the start of the trial the mean LDL-cholesterol concentration was 9 mmol/L. All patients on the active drug arms in the TESLA trials continued on evolocumab 420 mg monthly, whereas those in the placebo group changed to active drug. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. The primary endpoint was the percent reduction from baseline in … Raal FJ, Stein EA, Dufour R, Turner T, Civeira F, Burgess L, Langslet G, Scott R, Olsson AG, Sullivan D, Hovingh GK, Cariou B, Gouni-Berthold I, Somaratne R, Bridges I, Scott R, Wasserman SM, Gaudet D; RUTHERFORD-2 Investigators. In patients with homozygous familial hypercholesterolaemia receiving stable background lipid-lowering treatment and not on apheresis, evolocumab 420 mg administered every 4 weeks was well tolerated and significantly reduced LDL cholesterol compared with placebo. TESLA was a two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C … TESLA was a two-part phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C … We aimed to assess the long-term safety and efficacy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab in a subset of patients with homozygous familial hypercholesterolaemia enrolled in an open-label, non-randomised phase 3 trial. From basic science to pathogenesis of atherothrombotic disease, to risk assessment and the latest therapy options, this medical reference book offers unparalleled coverage and expert guidance on lipidology in a straightforward, accessible, ... Participants received double-blind placebo subcutaneously once a month for 12 weeks. For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. You have reached the maximum number of saved studies (100). Treatment with evolocumab reduced Lipoprotein (a): When to Measure and How to Treat? In an open-label dose scheduling pilot study conducted as part of the TESLA trial, 8 patients with homozygous familial hypercholesterolaemia received subcutaneous evolocumab 420 mg every 4 weeks for 12 weeks, then 420 mg every 4 weeks for a further 12 weeks, followed by 420 mg every 2 weeks for 12 weeks. No serious clinical or laboratory adverse events occurred, and no anti-evolocumab antibody development was detected during the study. MeSH eCollection 2021 Jan 1. This site needs JavaScript to work properly. Baptist Healthcare System Inc. d/b/a Baptist Health Lexington, Lexington, Kentucky, United States, 40503, Shreveport, Louisiana, United States, 71103, Worcester, Massachusetts, United States, 01655, Bridgeton, Missouri, United States, 63044, Contact: Michelle Raymond    314-344-7093, Principal Investigator: Amir Alshekhlee, MD, Saint Louis, Missouri, United States, 63103, Principal Investigator: Randall Edgell, MD, The Community Hospital Group Inc. t/a JFK Medical Center, Contact: Briana DeCarvalho, MSN, RN    732-321-7000, Principal Investigator: Jawad Kirmani, MD, Principal Investigator: Hussain Siddiqui, MD, Feinstein Institute for Medical Research, Northwell, Manhasset, New York, United States, 11030, Contact: Prathusan Subramaniam, BS    516-881-7012, Principal Investigator: Osama O Zaidat, MD, MS, Contact: Kelsey Launchbury    503-418-1722, Principal Investigator: Hormozd Bozorgchami, MD, Charleston, South Carolina, United States, 29425, Principal Investigator: Sami Al Kasab, MD, DHR Health Institute for Research and Development, Principal Investigator: Patricia Fernandez, MD, The University of Texas Health Science Center at Houston, Principal Investigator: Albert J Yoo, M.D., PhD, Contact: Charlotte Gilman, RN    804-828-0374, Principal Investigator: Dennis J Rivet II, MD, Morgantown, West Virginia, United States, 26506, Milwaukee, Wisconsin, United States, 53233, Principal Investigator: Thomas J Wolfe, MD, Dr. Osama O. Zaidat, Neuroscience and Stroke Medical Director, Mercy Health Ohio. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805308. Precision Medicine in Oncology draws together the essential research driving the field forward, providing oncology clinicians and trainees alike with an illuminating overview of the technology and thinking behind the breakthroughs currently ... TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) is a two-part Phase 2/3 trial designed to evaluate the safety, tolerability and efficacy of evolocumab. Familial hypercholesterolaemia: PCSK9 inhibitors are coming. Frederick J Raal Carbohydrate and Lipid Metabolism Research Unit, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the instructions for use (IFU). Imaging evidence of moderate-large infarct defined as: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Found inside – Page 77Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double‐blind, placebo‐controlled trial. Raal FJ, Honarpour N, Blom DJ, et al. Principal Investigator: Santiago Ortega Gutierrez, M.D. Patients received evolocumab 420 mg subcutaneous once monthly for a minimum of 12 weeks, followed by every two weeks for another 12 weeks. Cochrane Database Syst Rev. TESLA was a two-part Phase 2/3 trial evaluating evolocumab in patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder characterized by severely elevated LDL-C at an early age. TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) is a two-part phase 2/3 trial designed to evaluate the safety, tolerability and efficacy of evolocumab. Found inside – Page 133... Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, doubleblind, placebo-controlled trial, ... 2014;370:1809-1819. Unable to load your collection due to an error, Unable to load your delegates due to an error, Collaborators, Evolocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), reduced LDL cholesterol by 16% in a pilot study. We now report results with evolocumab in a randomised, double-blind, placebo-controlled phase 3 trial. Evolocumab? Raal FJ, Honarpour N, Blom DJ, et al. Talk with your doctor and family members or friends about deciding to join a study. The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Stein EA, Gipe D, Bergeron J, Gaudet D, Weiss R, Dufour R, Wu R, Pordy R. Lancet. • The TESLA Part B trial randomized 50 patients with HoFH on stable lipid-lowering therapy (LLT) to evolocumab 420 mg SC Q4W (n = 33) or placebo (n = 17) for 12 weeks. Found inside – Page 129Table 3 Trials of PCSK9 inhibitor evolocumab in the PROFICIO Global Programme ... TESLA 26 49 Evolocumab Homozygous familial hypercholesterolemia (HoFH) 12. Choosing to participate in a study is an important personal decision. Epub 2013 Sep 6. : 10.1007/s12325-021-01720-y every two weeks for another 12 weeks, Bouisset F, Scott,... Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke many years Data Element Definitions submitting. 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