干旱区生态环境知识资源中心(Arid): Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction

Arid

DOI	10.1016/j.ahj.2024.06.007
	Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction
	d'Entremont, Marc-Andre; Lee, Shun Fu; Mian, Rajibul; Kedev, Sasko; Montalescot, Gilles; Cornel, Jan Hein; Stankovic, Goran; Moreno, Raul; Storey, Robert F.; Henry, Timothy D.; Skuriat, Elizabeth; Tyrwhitt, Jessica; Mehta, Shamir R.; Devereaux, P. J.; Eikelboom, John; Cairns, John A.; Pitt, Bertram; Jolly, Sanjit S.
通讯作者	d'Entremont, MA
来源期刊	AMERICAN HEART JOURNAL
ISSN	0002-8703
EISSN	1097-6744
出版年	2024
卷号	275 页码:173-182
英文摘要	Background Patients experiencing myocardial infarction (MI) remain at high risk of future major adverse cardiovascular events (MACE). While low-dose colchicine and spironolactone have been shown to decrease post-MI MACE, more data are required to confirm their safety and efficacy in an unselected post-MI population. Therefore, we initiated the CLEAR SYNERGY (OASIS 9) trial to address these uncertainties. Methods The CLEAR SYNERGY trial is a 2 x 2 factorial randomized controlled trial of low-dose colchicine 0.5 mg daily versus placebo and spironolactone 25 mg daily versus placebo in 7,062 post-MI participants who were within 72 hours of the index percutaneous coronary intervention (PCI). We blinded participants, healthcare providers, research personnel, and outcome adjudicators to treatment allocation. The primary outcome for colchicine is the first occurrence of the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia-driven revascularization. The coprimary outcomes for spironolactone are (1) the composite of the total numbers of cardiovascular death or new or worsening heart failure and (2) the first occurrence of the composite of cardiovascular death, new or worsening heart failure, recurrent MI or stroke. We finished recruitment with 7,062 participants from 104 centers in 14 countries on November 8, 2022, and plan to present the results in the fall of 2024. Conclusions CLEAR SYNERGY is a large international randomized controlled trial that will inform the effects of low- dose colchicine and spironolactone in largely unselected post-MI patients who undergo PCI. (ClinicalTrials.gov Identifier: NCT03048825). (Am Heart J 2024;275:173-182.)
类型	Article
语种	英语
开放获取类型	hybrid
收录类别	SCI-E
WOS记录号	WOS:001283313600001
WOS关键词	ALDOSTERONE BLOCKADE ; CLINICAL-TRIALS ; DISEASE ; EPLERENONE ; OUTCOMES ; STENT
WOS类目	Cardiac & Cardiovascular Systems
WOS研究方向	Cardiovascular System & Cardiology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/402811
推荐引用方式 GB/T 7714	d'Entremont, Marc-Andre,Lee, Shun Fu,Mian, Rajibul,et al. Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction[J],2024,275:173-182.
APA	d'Entremont, Marc-Andre.,Lee, Shun Fu.,Mian, Rajibul.,Kedev, Sasko.,Montalescot, Gilles.,...&Jolly, Sanjit S..(2024).Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction.AMERICAN HEART JOURNAL,275,173-182.
MLA	d'Entremont, Marc-Andre,et al."Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction".AMERICAN HEART JOURNAL 275(2024):173-182.