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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
POLY-ACS Trial 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.Check my eligibility
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.See study design
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.
POLY-ACS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stent placed in my heart's artery using a minimally invasive procedure.
POLY-ACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who adhered to antiplatelet drug therapy
Number of participants who adhered to statin therapy
Secondary outcome measures
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 • NCT006035901%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polypill
Control
POLY-ACS 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
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,655 Total Patients Enrolled
Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to aspirin, prasugrel, or rosuvastatin in the past.I had a stent placed in my heart's artery using a minimally invasive procedure.Your kidney function, measured by a test called estimated glomerular filtration rate, is very low.I have had surgery to improve blood flow to my heart.I am under 18 years old.I am currently on blood thinners.I do not have any health conditions that could shorten my life within the next month.I am allergic or cannot take part of the medication offered in the trial.I need medication to strengthen my heart's contractions or my heart pumps less blood than it should.
Research Study Groups:
This trial has the following groups:- Group 1: Polypill
- Group 2: Usual Care (individual medications prescribed by primary cardiologist)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current vacancies for participants in this trial?
"From what is published on clinicaltrials.gov, it appears that this study is not looking for more participants at this time. The trial was initially posted on October 1st, 2022 and was updated most recently on August 22nd, 2022. There are 2052 other trials currently underway that patients may be eligible for."
Answered by AI
What is the risk profile associated with Polypill use?
"While there is some data suggesting that Polypill is safe, as this is only a Phase 2 trial, there is no evidence yet of the medication's efficacy. Consequently, our team has given it a score of 2."
Answered by AI
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