Chronic Coronary Syndrome
Conditions
Keywords
aspirin, clopidogrel, Major Adverse Cardiovascular Events
Brief summary
Determine the long-term efficacy of clopidogrel compared with aspirin in reducing heart or brain attacks in patients with stable heart disease
Interventions
Aspirin
Clopidogrel
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age ≥18 years. 2. 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). 3. 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). 4. Agreement to give written informed consent.
Exclusion criteria
1. History of hypersensitivity to aspirin or clopidogrel. 2. Presence of non-cardiac comorbidity with life expectancy ≤2 years from randomization. 3. Plan for surgery or intervention which requires stopping antiplatelet agents ≥3 months. 4. Females with childbearing potential or breast-feeding. 5. 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. 6. Inability to have a complete follow-up for up to 5 years from randomization (e.g: high possibility of travelling outside the country). 7. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Four-point MACCE, defined as a composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Ischemic Stroke, and Ischemia-driven Revascularization. | 3 years | Clinical follow-up by out-patient clinic visits or phone calls |
Contacts
King Saud University