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Clinical Trials/NCT07572747
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

Sponsor
Khalid F Alhabib
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Khalid F Alhabib

Professor of Cardiology

Saudi Heart Association

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