48 Participants NeededMy employer runs this trial

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
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?

This trial explores whether taking a low-dose aspirin daily can benefit people with early signs of heart disease, even without symptoms. Researchers aim to determine if prescribing aspirin makes a difference compared to not taking it. Participants will be divided into two groups: one will take aspirin daily, and the other will not. Individuals with early signs of coronary artery disease, such as some calcium build-up in heart arteries, but without major heart issues like a heart attack or stroke, might be a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently prescribed aspirin or other antithrombotic medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-dose aspirin can lower the risk of heart attacks and strokes, but it may also increase bleeding risk. One study found that people who took aspirin experienced fewer heart attacks but faced a higher chance of serious bleeding. Another study showed similar results, with aspirin reducing heart problems but increasing bleeding events. Although low-dose aspirin is often used and generally safe, these findings emphasize the need to balance its benefits with the risk of bleeding when considering it as a treatment.12345

Why do researchers think this study treatment might be promising for heart disease?

Researchers are excited about using low-dose aspirin for heart disease because it offers a simple yet effective way to help prevent heart attacks. Unlike some other treatments that may involve complex medications or procedures, aspirin works by thinning the blood, which reduces the risk of blood clots forming in the arteries. This makes it an accessible option for many people, as it is both cost-effective and easy to administer with just one daily pill. Additionally, aspirin has been widely studied and has a long history of use, which gives researchers confidence in its safety profile.

What is the effectiveness track record for aspirin in treating heart disease?

Research has shown that low-dose aspirin can lower the risk of serious heart problems, such as heart attacks and strokes. Studies have found that people with a history of heart disease who take aspirin experience fewer of these events. One study found that individuals with Type 2 diabetes who took low-dose aspirin were less likely to have a heart attack than those who did not. However, aspirin can also increase the risk of serious bleeding, which is important to consider. In this trial, participants will receive either a low-dose aspirin prescription or no prescription to evaluate its effects. Overall, healthcare providers often recommend aspirin for people at higher risk of heart disease to help prevent further issues.12346

Are You a Good Fit for This Trial?

This trial is for adults with early signs of coronary artery disease found on heart scans, but who have not had a heart attack, stroke, or major artery procedures. Participants must be able to give consent and cannot already need aspirin or blood thinners, have severe illness, or recent serious bleeding.

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

Trial Overview

The study randomly assigns people with subclinical coronary artery disease to either receive a prescription for low-dose aspirin or no prescription at all. The goal is to see if running a larger trial like this is practical in real-world settings.

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+

Citations

Long-Term Effectiveness of Acetylsalicylic Acid in Primary ...

They found no significant benefit from aspirin in reducing the incidence of cardiovascular disease and evidenced a significant increase in all- ...

The aspirin heart disease prevention conundrum - PMC - NIH

Three clinical trials have been published that genotyped subjects and tested the effectiveness of daily aspirin in reducing cardiovascular ...

Association of Aspirin Use for Primary Prevention With ...

Aspirin use was associated with reductions in the primary cardiovascular composite outcome and increases in major bleeding risks in both low and ...

Potential Impact of the 2019 ACC/AHA Guidelines ...

Aspirin may be considered for primary prevention (class IIb) in patients 40 to 70 years that are at higher risk of atherosclerotic cardiovascular disease.

Low-dose aspirin linked to lower cardiovascular event risk ...

Adults with Type 2 diabetes who took low-dose aspirin were less likely to have a heart attack (42.4%) than the participants who did not take low ...

Recommendation: Aspirin Use to Prevent Cardiovascular ...

The evidence showed that aspirin use for primary prevention of CVD was associated with a decreased risk of myocardial infarction and stroke but ...