Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial

NCT07524335 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-3694
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Subclinical Atherosclerotic Cardiovascular Disease; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Monthly Recruitment Rate

  Average monthly patient recruitment rate: 0 ≤ Mean rate (patients/month) \< 2 = study not feasible; 2 ≤ Mean rate (patients/month) \< 4 = study feasible with protocol modifications; ≥ 4 Mean rate (patients/month) = study feasible without major protocol modifications.

  12 months following study enrollment initiation

Secondary Outcomes (5)

• Proportion of Eligible Patients Randomized

  12 months following study enrollment initiation

• Intervention Adherence

  From randomization to the end of follow-up (12 months)

• Intervention Persistence

  From randomization to end of follow-up (12 months)

• Proportion of Patients Lost to Follow-up

  End of follow-up (12 months)

• Barriers to Recruitment, Adherence, and Patient Retention

  From recruitment to the end of follow-up (12 months)

Other Outcomes (3)

• Major Adverse Cardiovascular Event (MACE) Rate

  From enrollment to the end of follow-up (12 months)

• Bleeding Rate (BARC 2, 3, 5)

  From enrollment to the end of follow-up (12 months)

• Adverse Event (AE) Rate and Serious Adverse Event (SAE) Rate

  From enrollment to the end of follow-up (12 months)

Study Arms (2)

Low-dose Aspirin Prescription

EXPERIMENTAL

Aspirin 81 mg orally once daily prescription

Drug: Prescription of Aspirin

No Prescription

OTHER

No prescription of aspirin 81 mg orally once daily

Drug: No prescription

Interventions

Prescription of Aspirin DRUG

Aspirin 81 mg orally once daily

Low-dose Aspirin Prescription

No prescription DRUG

No prescription of aspirin 81 mg orally once daily

No Prescription

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented coronary atherosclerosis, as defined by one of the following criteria:
• Coronary artery calcium (CAC) score \> 0;
• 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;
• 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.
• Willing and able to provide informed consent and comply with study procedures

You may not qualify if:

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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cyril Gagnon, MD

CONTACT

514-376-3330; cyril.gagnon@umontreal.ca

Samara Bloom, MSc

CONTACT

514-376-3330; samara.bloom@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, parallel-group pilot study

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CA (1)