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Not yet recruiting NCT07572747

Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries

Phase III Interventional Chronic Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Clopidgrel 75 mg daily.
Who it may be relevant to
Registry conditions: Chronic Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Aspirin
    Aspirin
  • Drug Clopidgrel 75 mg daily
    Clopidogrel

Primary outcome measures

  • Four-point MACCE, defined as a composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Ischemic Stroke, and Ischemia-driven Revascularization. [Time frame: 3 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07572747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗