Recruiting
Phase 3

Low-Dose Aspirin

Sponsor:

Montreal Heart Institute

Code:

NCT07524335

Conditions

Coronary Artery Disease

Subclinical Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Prescription of Aspirin

No prescription

Study Details

Brief summary:

In patients with subclinical coronary artery disease, the ASCAD-P study aims to assess the feasibility of a larger phase 3 pragmatic randomized controlled trial comparing prescription versus no prescription of low-dose aspirin in routine clinical practice.

Conditions

Coronary Artery Disease

Subclinical Atherosclerotic Cardiovascular Disease

Study ID

NCT07524335

Start date

Jul 21, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jul 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Documented coronary atherosclerosis, as defined by one of the following criteria:

1. Coronary artery calcium (CAC) score > 0;
2. Cardiac CT angiography (CCTA) / CoroScan: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery;
3. Coronary angiography: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery; if performed, physiological coronary assessments (FFR, dPR, iFR, etc.) and intracoronary imaging (IVUS or OCT) must be negative for significant disease.
2. Willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

1. History of myocardial infarction (MI), coronary revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial revascularization procedure;
2. Current prescription or clear indication for aspirin, low-molecular-weight heparin (LMWH), direct oral anticoagulants, or any other antithrombotic medication;
3. Clear contraindication to aspirin;
4. History of significant bleeding within the past year;
5. Severe illness with limited life expectancy (i.e., <5 years);
6. Any condition that, in the investigator's judgment, would make participation unsafe for the patient.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Low-dose Aspirin Prescription

Aspirin 81 mg orally once daily prescription

other: No Prescription

No prescription of aspirin 81 mg orally once daily

Interventions

Prescription of Aspirin

Aspirin 81 mg orally once daily

No prescription

No prescription of aspirin 81 mg orally once daily

Primary outcome measure

  • Monthly Recruitment Rate [ Time Frame: 12 months following study enrollment initiation ]

Central Contacts and Locations

Locations

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

More Information

Sponsor

Montreal Heart Institute

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • Pilot Study
  • Feasability Study
  • Randomized
  • Clinical Trial
  • Prospective
  • Pragmatic Trial
  • Aspirin
  • Coronary artery disease
  • Bleeding
  • Major Adverse Cardiovascular Events
  • Antiplatelet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.