Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries

ConditionChronic Coronary Syndrome

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorKhalid F Alhabib

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Aspirin
Drug
Aspirin
Clopidgrel 75 mg daily
Drug
Clopidogrel

Treatment groups

6,740 Participants

are divided into 2 treatment groups

Group A: AspirinActive comparator 1 intervention

Group B: ClopidogrelActive comparator 1 intervention

Trial outcomes

Primary outcomes

Four-point MACCE, defined as a composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Ischemic Stroke, and Ischemia-driven Revascularization.

Clinical follow-up by out-patient clinic visits or phone calls

Time frame

3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khalid F Alhabib

Lead sponsor

Saudi Heart Association

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: