140 Participants Needed

Polypill for Acute Coronary Syndrome

(POLY-ACS Trial)

AP
Overseen ByAmbarish Pandey, MD, MSCS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Statins, Aspirin, Clopidogrel, Prasugrel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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?

Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low. This contributes to worse patient outcomes and increased risk of morbidity and mortality. The once-daily polypill leverages a population-based strategy that has previously demonstrated efficacy in improving adherence and access to therapy in low-resource settings, making it an innovative approach for improving post-ACS care. This study aims to investigate the utility of a polypill-based strategy for patients with ACS with drug eluting stent (DES) placement. The polypill will consist of a high-intensity statin (rosuvastatin 40 mg daily), aspirin 81 mg daily, and either clopidogrel 75 mg or prasugrel 10 mg daily.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, if you have a contraindication (reason not to take) to any component of the polypill, you may not be eligible to participate.

Is the polypill safe for humans?

Research shows that the polypill is generally safe for humans, as studies found no increase in serious adverse events compared to other treatments. It also helps improve medication adherence, which can lead to better health outcomes.12345

What makes the Polypill drug unique for treating acute coronary syndrome?

The Polypill is unique because it combines multiple medications into a single pill, which can simplify treatment by reducing the number of pills a patient needs to take. This can improve adherence to the treatment plan, potentially leading to better outcomes for patients with acute coronary syndrome.678910

What data supports the effectiveness of the Polypill drug for Acute Coronary Syndrome?

The research highlights that medications improving outcomes in heart failure with reduced ejection fraction (HFrEF) are often underused, and the involvement of clinical pharmacists can optimize these treatments. This suggests that a comprehensive approach, like the Polypill, which combines multiple medications, could be effective in managing complex heart conditions by ensuring patients receive all necessary drugs at appropriate doses.1112131415

Who Is on the Research Team?

Ambarish Pandey, M.D.: Internal ...

Ambarish Pandey, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

You have had a bad reaction to aspirin, prasugrel, or rosuvastatin in the past.
Pregnancy
Your kidney function, measured by a test called estimated glomerular filtration rate, is very low.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed-dose polypill consisting of rosuvastatin, aspirin, and either clopidogrel or prasugrel daily

1 month
Monthly visits for medication adherence assessment

Follow-up

Participants are monitored for adherence to medication and safety after treatment

1 month
1 visit (in-person) for lab draw and adherence assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Control treatment
  • Polypill
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: PolypillExperimental Treatment1 Intervention
Group II: Usual Care (individual medications prescribed by primary cardiologist)Active Control1 Intervention

Control treatment is already approved in European Union for the following indications:

🇪🇺
Approved in European Union as Trinomia for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Published Research Related to This Trial

In a study of 110 patients with heart failure and reduced ejection fraction (HFrEF), the inclusion of clinical pharmacists in the healthcare team significantly increased the percentage of patients reaching target doses of key medications, such as ACE inhibitors and beta blockers, from 0% to 77.4% and from 8.6% to 66.1%, respectively.
The up-titration of these medications led to notable improvements in clinical outcomes, including better ejection fraction and enhanced scores on the New York Heart Association (NYHA) scale, demonstrating the effectiveness of pharmacist interventions in managing heart failure.
Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan.Ahmed, KO., Taj Eldin, I., Yousif, M., et al.[2022]
The 2021 European Society of Cardiology guidelines emphasize the importance of early treatment with all four key drug classes for heart failure with reduced ejection fraction (HFrEF), which include ACE inhibitors, ARNI, beta-blockers, MRAs, and SGLT2 inhibitors.
This article serves as a practical guide for physicians to ensure safe and effective management of HFrEF, highlighting the need for comprehensive treatment strategies to improve patient outcomes.
[A practical approach to guideline-directed pharmacological treatment for heart failure with reduced ejection fraction].Soltani, S., Böhm, M., Frey, N., et al.[2022]
Heart failure with reduced ejection fraction (HFrEF) remains a serious condition with high mortality and hospitalization rates, highlighting the urgent need for effective pharmacological treatments.
Recent innovations in drug therapies for HFrEF are changing the treatment landscape, with ongoing studies focusing on both newly approved medications and experimental approaches to improve patient outcomes.
Innovations in medical therapy of heart failure with reduced ejection fraction.Mercurio, V., Ambrosio, G., Correale, M., et al.[2023]

Citations

Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. [2022]
[A practical approach to guideline-directed pharmacological treatment for heart failure with reduced ejection fraction]. [2022]
Innovations in medical therapy of heart failure with reduced ejection fraction. [2023]
Evaluation of Quality of Care for US Veterans With Recent-Onset Heart Failure With Reduced Ejection Fraction. [2022]
Effectiveness of drug interventions to prevent sudden cardiac death in patients with heart failure and reduced ejection fraction: an overview of systematic reviews. [2021]
[When will we treat patients with a polypill shortly after myocardial infarction?] [2023]
Patients' views about taking a polypill to manage cardiovascular risk: a qualitative study in primary care. [2022]
Improving cardiovascular protection: focus on a cardiovascular polypill. [2018]
Meta-Analysis on the Clinical Outcomes With Polypills for Cardiovascular Disease Prevention. [2023]
Benefits, challenges, and registerability of the polypill. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Is there a role for calcium channel blockers in congestive heart failure? [2019]
[Current aspects of thrombolytic therapy in unstable angina pectoris]. [2019]
[Current therapeutic strategies in acute coronary syndrome. New and established drug and interventional therapy]. [2010]
14.United Statespubmed.ncbi.nlm.nih.gov
Pharmacological approaches for the prevention of restenosis after percutaneous coronary intervention. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Calcium antagonists in patients with left ventricular dysfunction: back on the bridge? [2019]
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