Health TrialsbyHealthPanel

A Polypill for Acute Coronary Syndrome

ConditionAcute Coronary Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Hospitalization for acute coronary syndrome with percutaneous coronary intervention

Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin

Disqualifiers

Current need for systemic anticoagulation

Contraindication to receive any components of the polypill

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

Comorbidities that might be expected to limit lifespan within the 12-month study period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polypill

    Combination product

    The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: PolypillExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Win ratio

The win ratio will include all-cause death, in-stent thrombosis, ischemic events (MI, hospitalization for unstable angina, unplanned revascularization), and bleeding events (hospitalization or ED visit for bleeding, red blood cell transfusion, or a bleeding event that leads to cessation of DAPT)

Time frame
6-months

Secondary outcomes

1

Medication adherence

Medication adherence will be evaluated with the Morisky Medication Adherence Score (MMAS) and pill counts

Time frame
6-months
2

Treatment satisfaction

Treatment satisfaction will be measured using the validated Treatment Satisfaction Questionnaire for Medication (TSQM)

Time frame
6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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