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Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07572747
Acronym
ARCTURUS-GTC-1
Enrollment
6740
Registered
2026-05-07
Start date
2027-04-01
Completion date
2032-04-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome

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

DRUGAspirin

Aspirin

Clopidogrel

Sponsors

Khalid F Alhabib
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Four-point MACCE, defined as a composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Ischemic Stroke, and Ischemia-driven Revascularization.3 yearsClinical follow-up by out-patient clinic visits or phone calls

Contacts

CONTACTKhalid Alhabib
khalidalhabib13@hotmail.com+966505403354
CONTACTHani Altaradi
hanialtaradi@yahoo.com+966554742599
PRINCIPAL_INVESTIGATORKhalid Alhabib

King Saud University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026