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Aspirin for Heart Disease

(ASCAD-P Trial)

CG
SB
Overseen BySamara Bloom, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Montreal Heart Institute
Must not be taking: Aspirin, Antithrombotics
Disqualifiers: Myocardial infarction, Stroke, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

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
See 2 more

Exclusion Criteria

I have had a heart attack, stroke, TIA, or artery surgery in the past.
Severe illness with limited life expectancy (i.e., <5 years)
Clear contraindication to aspirin
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either low-dose aspirin or no prescription for 12 months

12 months

Follow-up

Participants are monitored for adherence, persistence, and clinical outcomes including MACE and bleeding events

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Aspirin

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: No PrescriptionExperimental Treatment1 Intervention
Group II: Low-dose Aspirin PrescriptionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials
125
Recruited
85,400+

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