Aspirin Versus Clopidogrel for Secondary Prevention of Atherosclerotic Cardiovascular Events in Patients With Chronic Coronary Syndrome in the Arabian Gulf Countries: A Randomized, Open-label, Multi-Center Trial by the Gulf Trialists' Collaboration

Khalid F Alhabib0 个研究点目标入组 6,740 人开始时间: 2027年4月1日最近更新: 2026年5月11日

适应症

试验速览

Determine the long-term efficacy of clopidogrel compared with aspirin in reducing heart or brain attacks in patients with stable heart disease

•Age ≥18 years.
•Significant coronary artery disease (coronary angiogram documentation of Left Main artery lesion ≥50% and/or lesion(s) ≥70% in other coronary arteries, and/or FFR<0.8 or iFR<0.9).
•Completed at least 6 months post ACS (regardless of the bleeding risk, anti-platelet strategy, revascularization strategy "PCI, CABG, or conservative medical management only", before randomization).
•Agreement to give written informed consent.

•History of hypersensitivity to aspirin or clopidogrel.
•Presence of non-cardiac comorbidity with life expectancy ≤2 years from randomization.
•Plan for surgery or intervention which requires stopping antiplatelet agents ≥3 months.
•Females with childbearing potential or breast-feeding.
•Co-administration of contraindicated medications as follows: anticoagulants (warfarin, direct oral anticoagulants (DOACs), or chronic therapy of heparin); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (≥15 mg/week); lithium.
•Inability to have a complete follow-up for up to 5 years from randomization (e.g: high possibility of travelling outside the country).
•Inability to afford paying for Clopidogrel out-of-pocket up to 5 years from randomization (in case not being covered by the health care system).

发起方

Khalid F Alhabib

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Khalid F Alhabib

Professor of Cardiology

Saudi Heart Association