A Polypill for Acute Coronary Syndrome

Summary

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.

Timeline

Start

2025-12-05

Primary completion

2030-06-01

Completion

2030-07-31

Publications

• Background Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):e344-426. doi: 10.1161/CIR.0000000000000134. Epub 2014 Sep 23. No abstract available.
• Background Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available.
• Background Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
• Background Okkonen M, Havulinna AS, Ukkola O, Huikuri H, Pietila A, Koukkunen H, Lehto S, Mustonen J, Ketonen M, Airaksinen J, Kesaniemi YA, Salomaa V. Risk factors for major adverse cardiovascular events after the first acute coronary syndrome. Ann Med. 2021 Dec;53(1):817-823. doi: 10.1080/07853890.2021.1924395.
• Background Islek D, Alonso A, Rosamond W, Kucharska-Newton A, Mok Y, Matsushita K, Koton S, Blaha MJ, Ali MK, Manatunga A, Vaccarino V. Differences in incident and recurrent myocardial infarction among White and Black individuals aged 35 to 84: Findings from the ARIC community surveillance study. Am Heart J. 2022 Nov;253:67-75. doi: 10.1016/j.ahj.2022.05.020. Epub 2022 Jun 1.
• Background Bradley EH, Herrin J, Wang Y, McNamara RL, Webster TR, Magid DJ, Blaney M, Peterson ED, Canto JG, Pollack CV Jr, Krumholz HM. Racial and ethnic differences in time to acute reperfusion therapy for patients hospitalized with myocardial infarction. JAMA. 2004 Oct 6;292(13):1563-72. doi: 10.1001/jama.292.13.1563.
• Background Garcia M, Almuwaqqat Z, Moazzami K, Young A, Lima BB, Sullivan S, Kaseer B, Lewis TT, Hammadah M, Levantsevych O, Elon L, Bremner JD, Raggi P, Shah AJ, Quyyumi AA, Vaccarino V. Racial Disparities in Adverse Cardiovascular Outcomes After a Myocardial Infarction in Young or Middle-Aged Patients. J Am Heart Assoc. 2021 Sep 7;10(17):e020828. doi: 10.1161/JAHA.121.020828. Epub 2021 Aug 25.
• Background Graham GN, Jones PG, Chan PS, Arnold SV, Krumholz HM, Spertus JA. Racial Disparities in Patient Characteristics and Survival After Acute Myocardial Infarction. JAMA Netw Open. 2018 Nov 2;1(7):e184240. doi: 10.1001/jamanetworkopen.2018.4240.
• Background Bucholz EM, Ma S, Normand SL, Krumholz HM. Race, Socioeconomic Status, and Life Expectancy After Acute Myocardial Infarction. Circulation. 2015 Oct 6;132(14):1338-46. doi: 10.1161/CIRCULATIONAHA.115.017009. Epub 2015 Sep 14.
• Background Udell JA, Desai NR, Li S, Thomas L, de Lemos JA, Wright-Slaughter P, Zhang W, Roe MT, Bhatt DL. Neighborhood Socioeconomic Disadvantage and Care After Myocardial Infarction in the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004054. doi: 10.1161/CIRCOUTCOMES.117.004054.
• Background Rao S, Jamal Siddiqi T, Khan MS, Michos ED, Navar AM, Wang TJ, Greene SJ, Prabhakaran D, Khera A, Pandey A. Association of polypill therapy with cardiovascular outcomes, mortality, and adherence: A systematic review and meta-analysis of randomized controlled trials. Prog Cardiovasc Dis. 2022 Jul-Aug;73:48-55. doi: 10.1016/j.pcad.2022.01.005. Epub 2022 Feb 1.
• Background Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.
• Background Castellano JM, Sanz G, Penalvo JL, Bansilal S, Fernandez-Ortiz A, Alvarez L, Guzman L, Linares JC, Garcia F, D'Aniello F, Arnaiz JA, Varea S, Martinez F, Lorenzatti A, Imaz I, Sanchez-Gomez LM, Roncaglioni MC, Baviera M, Smith SC Jr, Taubert K, Pocock S, Brotons C, Farkouh ME, Fuster V. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021. Epub 2014 Sep 1.
• Background Wang TJ. The Polypill at 20 - What Have We Learned? N Engl J Med. 2022 Sep 15;387(11):1034-1036. doi: 10.1056/NEJMe2210020. Epub 2022 Aug 26. No abstract available.
• Background Roshandel G, Khoshnia M, Poustchi H, Hemming K, Kamangar F, Gharavi A, Ostovaneh MR, Nateghi A, Majed M, Navabakhsh B, Merat S, Pourshams A, Nalini M, Malekzadeh F, Sadeghi M, Mohammadifard N, Sarrafzadegan N, Naemi-Tabiei M, Fazel A, Brennan P, Etemadi A, Boffetta P, Thomas N, Marshall T, Cheng KK, Malekzadeh R. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet. 2019 Aug 24;394(10199):672-683. doi: 10.1016/S0140-6736(19)31791-X.

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Indications