Coronary Artery DiseasePhase 3ASCAD-PNCT07524335
Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
A Phase 3 study testing Prescription of Aspirin and No prescription in people with Coronary Artery Disease and Subclinical Atherosclerotic Cardiovascular Disease, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease, Subclinical Atherosclerotic Cardiovascular Disease
- What is being tested?
- Prescription of Aspirin and No prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2026to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Samara Bloom, BSc, MSc, 514-376-3330 ext. 2698, Samara.Bloom@icm-mhi.org
About this study
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.
Read the detailed description
Cardiovascular disease remains the leading cause of mortality worldwide. Recent large randomized trials have demonstrated limited net clinical benefit of aspirin in unselected primary prevention populations, leading to guideline recommendations against its systematic routine use for cardiovascular protection.
Patients with subclinical coronary artery disease represent a high-risk subgroup. These individuals have documented coronary artery disease but have not experienced overt cardiovascular events or undergone revascularization. Observational data suggest that this population carries a substantially increased risk of myocardial infarction compared with individuals without coronary atherosclerosis. However, the benefit-risk balance of aspirin in this intermediate-risk group remains uncertain
Primary Objective:
To evaluate the recruitment rate of a pilot randomized trial comparing low-dose aspirin prescription versus no prescription.
Secondary Objectives
To evaluate key feasibility metrics, including:
- The proportion of eligible patients who are randomized;
- Adherence and persistence to the assigned intervention at 12 months;
- The proportion of patients who do not complete the 12-month follow-up;
- Barriers to recruitment, adherence, and retention.
Exploratory Objectives:
To explore clinical outcomes at 12 months, including:
- The incidence of clinically significant bleeding events (BARC type 2, 3, or 5) and bleeding site;
- The incidence of major adverse cardiovascular events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization;
- Individual components of the composite endpoint;
- Cardiovascular mortality;
- Adverse Events and Serious Adverse Events.
- Being tested
- Prescription of Aspirin, No prescription
- Keywords
- Pilot Study, Feasability Study, Randomized, Clinical Trial, Prospective, Pragmatic Trial, Aspirin, Coronary artery disease, Bleeding, Major Adverse Cardiovascular Events, Antiplatelet
- Medical subject headings
- Coronary Artery Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription of AspirinDrug
Aspirin 81 mg orally once daily
No prescriptionDrug
No prescription of aspirin 81 mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Aspirin Prescription | Experimental | Aspirin 81 mg orally once daily prescription Receives: Drug: Prescription of Aspirin |
| No Prescription | Other | No prescription of aspirin 81 mg orally once daily Receives: Drug: No prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months following study enrollment initiation
Secondary outcomes (5)
Proportion of Eligible Patients Randomized
Proportion of eligible patients who are randomized:
0% ≤ Proportion < 30% = study not feasible, major protocol modifications required; 30% ≤ Proportion < 61% = study feasible with protocol modifications;
≥ 61% = study feasible without protocol modifications.
Measured: 12 months following study enrollment initiation
Intervention Adherence
Proportion of days on which patients take the assigned intervention (adherence):
0% ≤ Mean proportion < 25% = study not feasible, major protocol modifications required; 25% ≤ Mean proportion < 74% = study feasible with protocol modifications;
≥ 74% = study feasible without protocol modifications.
Measured: From randomization to the end of follow-up (12 months)
Intervention Persistence
Proportion of patients who still take the assigned intervention at 12 months of follow-up (persistence):
0% ≤ Proportion < 25% = study not feasible, major protocol modifications required; 25% ≤ Proportion < 70% = study feasible with protocol modifications;
≥ 70% = study feasible without protocol modifications.
Measured: From randomization to end of follow-up (12 months)
Proportion of Patients Lost to Follow-up
Proportion of patients who do not complete the 12-month follow-up visit:
≥ 10% = study not feasible, major protocol modifications required; 6% ≤ Proportion < 10% = study feasible with protocol modifications; 0% ≤ Proportion < 6% = study feasible without protocol modifications.
Measured: End of follow-up (12 months)
Barriers to Recruitment, Adherence, and Patient Retention
Measured: From recruitment to the end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start21 Jul 2026
- Primary completion21 Jul 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, parallel-group pilot study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume Marquis-Gravel, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524335
- Sponsor's protocol ID
- 2026-3694
- Acronym
- ASCAD-P
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07524335
- Acronym / sponsor ID
- ASCAD-P / 2026-3694
- Keywords
- Pilot Study, Feasability Study, Randomized, Clinical Trial, Prospective, Pragmatic Trial, Aspirin, Coronary artery disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease remains the leading cause of mortality worldwide. Recent large randomized trials have demonstrated limited net clinical benefit of aspirin in unselected primary prevention populations, leading to guideline recommendations against its systematic routine use for cardiovascular protection.
Patients with subclinical coronary artery disease represent a high-risk subgroup. These individuals have documented coronary artery disease but have not experienced overt cardiovascular events or undergone revascularization. Observational data suggest that this population carries a substantially increased risk of myocardial infarction compared with individuals without coronary atherosclerosis. However, the benefit-risk balance of aspirin in this intermediate-risk group remains uncertain
Primary Objective:
To evaluate the recruitment rate of a pilot randomized trial comparing low-dose aspirin prescription versus no prescription.
Secondary Objectives
To evaluate key feasibility metrics, including:
- The proportion of eligible patients who are randomized;
- Adherence and persistence to the assigned intervention at 12 months;
- The proportion of patients who do not complete the 12-month follow-up;
- Barriers to recruitment, adherence, and retention.
Exploratory Objectives:
To explore clinical outcomes at 12 months, including:
- The incidence of clinically significant bleeding events (BARC type 2, 3, or 5) and bleeding site;
- The incidence of major adverse cardiovascular events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization;
- Individual components of the composite endpoint;
- Cardiovascular mortality;
- Adverse Events and Serious Adverse Events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, parallel-group pilot study
| Arm | Type | Receives |
|---|---|---|
| Low-dose Aspirin Prescription | Experimental | Drug: Prescription of AspirinAspirin 81 mg orally once daily prescription |
| No Prescription | Other | Drug: No prescriptionNo prescription of aspirin 81 mg orally once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented coronary atherosclerosis, as defined by one of the following criteria:
- Willing and able to provide informed consent and comply with study procedures
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription of AspirinAspirin 81 mg orally once daily | Drug | Low-dose Aspirin Prescription |
| No prescriptionNo prescription of aspirin 81 mg orally once daily | Drug | No Prescription |
Primary outcome
Monthly Recruitment Rate
Time frame: 12 months following study enrollment initiation
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.
5 secondary outcomes
Proportion of Eligible Patients Randomized
Time frame: 12 months following study enrollment initiation
Intervention Adherence
Time frame: From randomization to the end of follow-up (12 months)
Intervention Persistence
Time frame: From randomization to end of follow-up (12 months)
Proportion of Patients Lost to Follow-up
Time frame: End of follow-up (12 months)
Barriers to Recruitment, Adherence, and Patient Retention
Time frame: From recruitment to the end of follow-up (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prescription of Aspirin and No prescription in people with Coronary Artery Disease and Subclinical Atherosclerotic Cardiovascular Disease, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyril Gagnon, MD (514-376-3330 ext. 2698, cyril.gagnon@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Recruitment Rate (time frame: 12 months following study enrollment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.