NCT07572747

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,740

participants targeted

Target at P75+ for phase_3

Timeline
61mo left

Started Apr 2027

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2027

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2032

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

April 28, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

aspirinclopidogrelMajor Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin

Drug: Clopidgrel 75 mg daily

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel

Drug: Aspirin

Interventions

Clopidogrel

Aspirin

Aspirin

Clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Khalid Alhabib

    King Saud University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 7, 2026

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share