Aspirin for Heart Disease
(ASCAD-P 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either low-dose aspirin or no prescription for 12 months
Follow-up
Participants are monitored for adherence, persistence, and clinical outcomes including MACE and bleeding events
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
No prescription of aspirin 81 mg orally once daily
Aspirin 81 mg orally once daily prescription
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montreal Heart Institute
Lead Sponsor
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.
5.
newsroom.heart.org
newsroom.heart.org/news/low-dose-aspirin-linked-to-lower-cardiovascular-event-risk-for-adults-with-type-2-diabetesLow-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 ...
6.
uspreventiveservicestaskforce.org
uspreventiveservicestaskforce.org/uspstf/recommendation/aspirin-to-prevent-cardiovascular-disease-preventive-medicationRecommendation: 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 ...
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