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Polypill for Acute Coronary Syndrome (POLY-ACS Trial)

Phase 2

Recruiting

Led By Ambarish Pandey, MD, MSCS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.

Be older than 18 years old

Must not have

History of coronary artery bypass graft surgery

Age < 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a pill containing multiple medications can improve care for patients with a specific heart condition.

Who is the study for?

This trial is for adults with acute coronary syndrome who've had a stent placed. They must have normal kidney function and no history of bypass surgery, severe heart failure, or need for blood thinners. They can't be allergic to the polypill components (statin, aspirin, clopidogrel/prasugrel) and should not have health issues limiting their life expectancy within a month.

What is being tested?

The study compares usual care with a 'polypill' strategy post-stent placement in patients with acute coronary syndromes. The polypill includes rosuvastatin (for cholesterol), aspirin, and clopidogrel/prasugrel (blood thinners). It's designed to improve medication adherence and outcomes.

What are the potential side effects?

Possible side effects include muscle pain from statins; bleeding risks from aspirin and other blood thinners; potential liver issues due to rosuvastatin; as well as general risks like allergies or intolerance to any of the pill's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stent placed in my heart's artery using a minimally invasive procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to improve blood flow to my heart.

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I am under 18 years old.

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I am currently on blood thinners.

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I am allergic or cannot take part of the medication offered in the trial.

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I need medication to strengthen my heart's contractions or my heart pumps less blood than it should.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who adhered to antiplatelet drug therapy

Number of participants who adhered to statin therapy

Secondary study objectives

Number of participants who adhered to medication as assessed MMAS-8 questionnaire

Number of participants who adhered to medication as assessed by pill count

Side effects data

From 2008 Phase 2 trial • 475 Patients • NCT00603590

Cough

100%

80%

60%

40%

20%

Study treatment Arm

Polypill

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PolypillExperimental Treatment1 Intervention

Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.

Group II: Usual Care (individual medications prescribed by primary cardiologist)Active Control1 Intervention

Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polypill

2011

Completed Phase 3

~2880

0 / 6Eligibility criteria met