Polypill for Acute Coronary Syndrome
(POLY-ACS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Statins, Aspirin, Clopidogrel, Prasugrel
Must not be taking: Anticoagulants
Disqualifiers: Renal failure, Cardiac support, Pregnancy, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.12345
Is the polypill safe for humans?
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.1112131415
Eligibility Criteria
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.
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Trial Timeline
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
Treatment Details
Interventions
- Control treatment (Other)
- Polypill (Combination Therapy)
Trial OverviewThe 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.
Participant Groups
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.
Control treatment is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as Trinomia for:
- Secondary prevention of cardiovascular events in patients who have experienced a myocardial infarction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Southwestern Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. [2022]Medications known to improve outcomes in heart failure (HF) are either not prescribed or prescribed at sub-therapeutic doses. The addition of clinical pharmacists to the HF team positively impacts optimizing prognostic medications for a patient with HF with reduced ejection fraction (HFrEF).
[A practical approach to guideline-directed pharmacological treatment for heart failure with reduced ejection fraction]. [2022]The 2021 guidelines of the European Society of Cardiology for the diagnosis and treatment of heart failure recommend the early implementation of all four mortality-lowering drug classes for heart failure with reduced ejection fraction (HFrEF), i. e. angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor II blocker-neprilysin inhibitor (ARNI), betablocker (BB), mineralocorticoid receptor-antagonists (MRA), and sodium-glucose linked transporter-2 inhibitors (SGLT2i). This article aims to give a practical compendium supporting physicians to enable safe and efficacious treatment for patients with HFrEF.
Innovations in medical therapy of heart failure with reduced ejection fraction. [2023]Heart failure with reduced ejection fraction (HFrEF) is a pathological condition still characterized by high rates of mortality and disease exacerbation frequently leading to hospitalization, thus there is a continuous need for pharmacological treatments impacting on disease stability and long-term prognosis. Moreover, the phenotype of heart failure patients is continuously changing over time, and the development of new heart failure drugs is crucial to promote a personalized and targeted approach. In recent years, several therapeutic innovations have emerged in the landscape of acute and chronic HFrEF, largely changing and improving our approach to the disease. Various studies on new drugs and experimental therapeutic approaches are ongoing. The present review discusses the latest data on both recently approved drugs and developing therapeutic targets, in order to provide a critical overview for an informed and optimal approach to such a complex disease.
Evaluation of Quality of Care for US Veterans With Recent-Onset Heart Failure With Reduced Ejection Fraction. [2022]Multiple guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF) are available and promoted by performance measures. However, contemporary data on the use of these therapies are limited.
Effectiveness of drug interventions to prevent sudden cardiac death in patients with heart failure and reduced ejection fraction: an overview of systematic reviews. [2021]To summarise and synthesise the current evidence regarding the effectiveness of drug interventions to prevent sudden cardiac death (SCD) and all-cause mortality in patients with heart failure with reduced ejection fraction (HFrEF).
[When will we treat patients with a polypill shortly after myocardial infarction?] [2023]The 'polypill' stands for fixed-dosed combination pills with generic drugs that act on multiple cardiovascular risk factors. Data from randomized controlled trials show consistent beneficial effects of treatment with a polypill on both cardiovascular risk factors and relevant marjor cardiovascular endpoints. However, polypills are not readily available worldwide and only a limited number of polypills is marketed in Europe. Physicians have to embrace polypills in regular care to let the patient benefit from the advantages of the polypill. Licensing more polypills is an essential step to implement these pills in clinical care. Regulatory agencies need to reduce the dossier content requirements for registrations of new fixed-dosed combination pills so generic pharmaceutical companies can expand the number of marketed polypills.
Patients' views about taking a polypill to manage cardiovascular risk: a qualitative study in primary care. [2022]A 'polypill' containing a combination of antihypertensives and statins could prevent up to 80% of cardiovascular disease (CVD) events.
Improving cardiovascular protection: focus on a cardiovascular polypill. [2018]Lack of adherence may explain, at least in part, the poor cardiovascular risk factors control observed in patients with ischemic heart disease, increasing the risk of developing new events. Polypill improves medication adherence, which may actually reduce blood pressure and LDL cholesterol compared with the drugs given separately. The fixed combination of acetylsalicylic acid 100 mg + ramipril 2.5, 5, or 10 mg + either simvastatin 40 mg or atorvastatin 20 mg is the unique cardiovascular polypill that has been registered in 22 countries worldwide. The polypill-containing simvastatin has been specifically tested in a clinical trial including only patients with ischemic heart disease. The FOCUS study showed that patients treated with the polypill showed a higher adherence compared with those receiving separate medications.
Meta-Analysis on the Clinical Outcomes With Polypills for Cardiovascular Disease Prevention. [2023]Randomized controlled trials (RCTs) examining the outcomes of "polypill" therapy in cardiovascular disease prevention have yielded mixed results. We performed an electronic search through January 2023 for RCTs that examined the use of polypills for cardiovascular disease primary or secondary prevention. The primary outcome was the incidence of major adverse cardiac and cerebrovascular events (MACCEs). The final analysis included 11 RCTs with 25,389 patients; 12,791 patients were in the polypill arm, and 12,598 patients were in the control arm. The follow-up period ranged from 1 to 5.6 years. Polypill therapy was associated with a lower risk of MACCE (5.8% vs 7.7%; risk ratio [RR] 0.78, 95% confidence interval [CI] 0.67 to 0.91). The reduction of MACCE risk was consistent in both primary and secondary prevention. Polypill therapy was associated with a lower incidence of cardiovascular mortality (2.1% vs 3%; RR 0.69, 95% CI 0.55 to 0.87), myocardial infarction (2.3% vs 3.2%; RR 0.72, 95% CI 0.61 to 0.84) and stroke (0.9% vs 1.6%; RR 0.62, 95% CI 0.42 to 0.90). Polypill therapy was associated with a higher degree of adherence. There was no difference between both groups in the incidence of serious adverse events (16.1% vs 15.9%; RR 1.12, 95% CI 0.93 to 1.36). In conclusion, we found that a polypill strategy was associated with a lower incidence of cardiac events and higher adherence, without an increased incidence of adverse events. This benefit was consistent for both primary and secondary prevention.
Benefits, challenges, and registerability of the polypill. [2013]Guidelines for the management of cardiovascular disease (CVD) stress the importance of treating global risk, rather than individual risk, factors. Patients at high cardiovascular (CV) risk, for example, benefit from a combination of aspirin, antihypertensive agents, lipid-lowering drugs, and possibly folic acid. As the number of medications that a patient requires increases, adherence and compliance to therapy are likely to decrease. The use of affordable, multiple-target, fixed-combination 'polypills', which concomitantly reduce multiple risk factors without increasing the pill burden or the risk of adverse effects, has the potential to improve CV risk factor management, thereby reducing the incidence of CVD. This review discusses the benefits of the polypill and the challenges and requirements for its success and registerability. Discussions with regulatory bodies are required in order to obtain some 'balance' between an overcautious registration approach and the potentially large public health benefits that are likely to arise from the use of polypills.
Is there a role for calcium channel blockers in congestive heart failure? [2019]Over the past several decades, we have made great strides in understanding the pathophysiology of heart failure and have developed new therapeutic targets based on utilizing several different models in clinical trials. Currently, standard therapy involves angiotensin-converting enzyme inhibitors and beta-blockers. In an effort to further reduce mortality, investigators focused on other vasodilators (calcium channel blockers) that might prove to be advantageous when added to standard therapy. Large- scale trials showed that the calcium channel blockers did not have a specific role in mortality reduction, but the third-generation dihydropyridine calcium channel blockers were safe to use in patients with heart failure.
[Current aspects of thrombolytic therapy in unstable angina pectoris]. [2019]In the last years, several studies addressed the role of the different antithrombotic therapeutics in unstable angina pectoris. Acetylsalicylic acid still is the standard treatment reducing the rate of death and myocardial infarction by 50% in the first six months. Ticlopidin has no clinical effect in the first six days and therefore is not suited for treatment in the acute phase. Unfractionated heparin has an additional favourable effect when added to aspirin. Low molecular weight-heparin is at least as effective as UF-heparin. Direct thrombin-inhibitors (hirudin, hirudin-analoga) seem to be comparable to UF-heparin. Plasminogen-activators should not be given in unstable angina, as they show a tendency to worsen the clinical outcome. GP IIb/IIIa-antagonists (antibodies, synthetic antagonists) significantly improve the clinical effects of aspirin. When combined with a reduced dose of heparin, their favourable effect remains unchanged, while bleeding complications are reduced to a minimum.
[Current therapeutic strategies in acute coronary syndrome. New and established drug and interventional therapy]. [2010]Therapeutic options in acute coronary syndrome (unstable angina pectoris/non-Q-wave myocardial infarction), as also in acute Q-wave infarction, include conservative medical and mechanical-interventional measures. Early hospitalization for surveillance and induction of treatment is always necessary. Administration of oxygen, analgesia, sedation and treatment with nitrates, beta blockers or calcium antagonists, acetylsalicylic acid (ASA) and heparin are the basic measures. As alternatives to ASA, the new ADP antagonists, ticlopidine, clopidogrel, and as an alternative to heparin, hirudin or low-molecular-weight heparins can be used. If this does not result in rapid clinical stabilisation (here, transient ST-T changes in the ECG and the detection of troponine I or T represent major risk indicators) the new glycoprotein-IIb/IIIa receptor antagonists may be employed as highly potent platelet aggregation inhibitors. In addition, the patients should then undergo coronary angiography prior to interventional treatment of the underlying coronary stenosis.
Pharmacological approaches for the prevention of restenosis after percutaneous coronary intervention. [2021]A large number of drug trials for prevention of restenosis have been conducted with many showing little or conflicting benefit. Antiplatelets such as aspirin, ticlopidine and thromboxane A2 receptor inhibitors have not shown a clear benefit. Similarly, antithrombotics, either acting indirectly such as heparin, or as direct thrombin inhibitors such as hirudin and hirulog, do not prevent restenosis. Trials with ACE inhibitors, HMG-CoA reductase inhibitors and fish-oil supplements have yielded inconclusive results. The antiproliferatives, angiopeptin, trapidil and tranilast have shown some benefit in small-scale studies. Other drug classes of potential benefit include the glycoprotein IIb/IIIa receptor antagonists, inhibitors of the early coagulation cascade, calcium channel blockers and nitric oxide donors. Drug research into restenosis prevention has been hampered by problems with the definition of restenosis and the applicability in humans of animal models. Although no single drug has conclusively proven effective yet, the promise of a number of agents, together with other nonpharmacological strategies will likely result in further reductions in the incidence of restenosis.
Calcium antagonists in patients with left ventricular dysfunction: back on the bridge? [2019]Calcium antagonists have a useful role in the management of patients with cardiac disease, producing coronary and systemic vasodilatation and an additional possibly beneficial effect on ventricular diastolic function. On the other hand, the myocardial depressant effect of the first-generation drugs and the abrupt changes in blood pressure, with neurohormonal activation, have been associated with worsening heart failure in certain patients. The present review summarizes the data currently available, with emphasis on the newer slow-release and long-acting calcium antagonists. Use of these drugs minimizes the peak and trough effect associated with short-acting preparations, and particularly when administered against a background of digoxin, diuretic and angiotensin converting enzyme inhibitors, may be associated with better long-term results in patients with ventricular dysfunction. The DEFIANT studies, using nisoldipine-coat core, showed that nisoldipine-CC improved diastolic ventricular function and had a significant anti-ischemic effect in patients with mild-moderate ventricular dysfunction after acute myocardial infarction. The VHeFT III trial showed that felodipine had no effect on exercise capacity or survival in patients with Class 2-3 heart failure. In the PRAISE study of Class 3-4 patients, amlodipine was neutral in patients with ischemic disease, but a strikingly beneficial effect was observed in non-ischemic heart failure (45% decrease in mortality). The precise mechanism for the beneficial effect of amlodipine in these patients is unknown. Further studies are needed to examine the issue of survival benefit in patients with non-ischemic heart failure and the mechanisms involved.