Polypill for Acute Coronary Syndrome

(PolyACS Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Aspirin, P2Y12 inhibitors, Statins

Must not be taking: Anticoagulants

Disqualifiers: Allergy to aspirin, Pregnancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining standard heart medications into one pill can improve recovery after a heart attack. The polypill includes aspirin, a blood thinner (such as prasugrel or clopidogrel), and a cholesterol-lowering drug (rosuvastatin). Researchers aim to determine if taking one pill enhances medication adherence and health outcomes. Individuals hospitalized for a heart attack and currently taking these medications separately might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires participants to be discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin. You should discuss your current medications with the trial team to see if they fit with the study requirements.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the polypill, which combines aspirin, a strong cholesterol-lowering drug (rosuvastatin), and a blood thinner (either clopidogrel or prasugrel), is generally well-tolerated by patients. These drugs are commonly used individually and are known to be safe when taken separately.

The polypill aims to simplify treatment by combining these medications into one pill, helping people adhere to their medication regimen more easily, as it's simpler to remember one pill instead of three.

Studies on similar polypills have not identified any new safety concerns, suggesting that combining these drugs in one pill does not introduce new risks. However, like any medication, side effects can occur. Common side effects include stomach upset and muscle pain, but serious issues are rare.

The current trial has reached an advanced stage, indicating that substantial safety information is already available. This typically suggests that the treatment is safe enough for testing on a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The polypill is unique because it combines multiple medications—aspirin, rosuvastatin, and either prasugrel or clopidogrel—into a single pill, which simplifies treatment for acute coronary syndrome. This approach differs from the standard regimen, where patients take each medication separately, potentially improving adherence and ensuring that patients receive the full spectrum of therapy. Researchers are excited about the polypill because it could make it easier for patients to stick to their medication plan, potentially leading to better outcomes by reducing the risk of further heart issues.

What evidence suggests that this polypill is effective for acute coronary syndrome?

Research has shown that combining medications into a single "polypill" can significantly improve health outcomes for people with acute coronary syndrome (ACS). Studies have found that a polypill, which includes aspirin, statins, and other heart medications, can reduce the risk of further heart problems by about 25%. This method works well because it simplifies medication intake, leading to better adherence and improved heart health. In this trial, participants in the experimental arm will receive a polypill containing aspirin, a strong statin, and either clopidogrel or prasugrel, all of which aid heart recovery and prevent new blood clots. This evidence suggests that using a polypill could effectively lower the risk of future heart issues in people recovering from ACS. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently experienced an acute coronary syndrome (ACS), which includes conditions like heart attacks or chest pain from blocked arteries. Participants should be prescribed standard ACS medications such as aspirin, P2Y12 inhibitors, and statins.

Inclusion Criteria

I am 18 years old or older.

I am taking aspirin, prasugrel or clopidogrel, and a high-intensity statin.

I was hospitalized for a heart issue and had a procedure to open my heart's arteries.

Exclusion Criteria

Inability to provide written informed consent

Pregnancy

History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a polypill consisting of a high-intensity statin, aspirin 81 mg, and a P2Y12 inhibitor

12 months

Regular follow-up visits as per trial protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Polypill

Trial Overview The study tests if a single 'polypill' combining aspirin, P2Y12 inhibitors, and statins can improve patient outcomes after an ACS event. It's a practical trial conducted across multiple centers where participants are randomly assigned to receive the polypill or their usual separate medications.

How Is the Trial Designed?

Group I: Polypill Experimental Treatment 1 Intervention

The polypill combines DAPT and a high intensity statin: (a) aspirin 81 mg, (b) rosuvastatin (40 or 10 mg) and (c) prasugrel 10 mg or clopidogrel 75 mg.

Group II: Usual care Active Control 1 Intervention

Participants in the usual care arm will be prescribed DAPT and statins as standard therapy in individual pills.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07032389

NCT07032389 | A Polypill for Acute Coronary Syndrome In the SECURE trial, patients with recent MI who were treated with a polypill containing aspirin, ramipril, and atorvastatin had a ~25% lower risk of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05514938

Polypill in Acute Coronary Syndrome (POLY-ACS) The polypill will consist of a high-intensity statin (rosuvastatin 40 mg daily), aspirin 81 mg daily, and clopidogrel 75 mg or prasugrel 10 mg daily. The ...

3. withpower.com withpower.com/trial/phase-2-lipid-disorders-9-2022-9b37b

Polypill for Acute Coronary Syndrome (POLY-ACS Trial) The up-titration of these medications led to notable improvements in clinical outcomes, including better ejection fraction and enhanced scores on the New York ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6500819/

Aspirin in combination with clopidogrel in the treatment of ... Conclusion: Aspirin combined with clopidogrel can effectively reduce the occurrence of re-thrombosis after PCI and improve the recovery of cardiac function ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-2-acute-coronary-syndrome-polypill-trial-nct05514938

Polypill in Acute Coronary Syndrome A Pilot Study of Polypill for Acute Coronary Syndrome. Evaluating the Use of a Combination Pill for Treating Acute Coronary Syndrome.

6. withpower.com withpower.com/trial/phase-3-acute-coronary-syndrome-9-2025-75fbc

Polypill for Acute Coronary Syndrome · Info for Participants Trial Overview The study tests if a single 'polypill' combining aspirin, P2Y12 inhibitors, and statins can improve patient outcomes after an ACS event. It's a ...

7. clinconnect.io clinconnect.io/trials/NCT07032389

A Polypill for Acute Coronary Syndrome (NCT07032389) The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, ...