NCT07572747Not yet recruitingPhase 3
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 sites6,740 target enrollmentStarted: April 1, 2027Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 6,740
Study Overview
Brief Summary
Determine the long-term efficacy of clopidogrel compared with aspirin in reducing heart or brain attacks in patients with stable heart disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Investigators
Khalid F Alhabib
Professor of Cardiology
Saudi Heart Association
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