Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries (ARCTURUS-GTC-1)

Khalid F Alhabib

Status and phase: Begins enrollment in 10 months; Phase 3

Conditions: Chronic Coronary Syndrome

Treatments: Drug: Clopidgrel 75 mg daily; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifier

NCT07572747

Details and patient eligibility

About

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

Enrollment: 6,740 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,740 participants in 2 patient groups

Aspirin

Active Comparator group

Description:

Aspirin

Treatment:

Drug: Clopidgrel 75 mg daily

Clopidogrel

Active Comparator group

Description:

Clopidogrel

Treatment:

Drug: Aspirin