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临床试验/NCT05514938
NCT05514938已完成2 期

Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Platelet Reactivity

研究概览

简要总结

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 or high-risk PCI. 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.

详细描述

Acute coronary syndromes (ACS) represent a large contributor to patient morbidity and mortality and healthcare costs. Patients with suspected ACS are referred for diagnostic coronary angiography, and if obstructive coronary disease is found, percutaneous coronary intervention (PCI) has been proven to reduce mortality and reduce recurrent myocardial infarction. Medical therapy for ACS involves treatment with a statin and dual antiplatelet drug therapy with aspirin and P2Y12 inhibition.

Dual antiplatelet therapy (DAPT) is a vital aspect of post-PCI care and ensures stent patency. Aspirin blocks metabolism of arachidonic acid and production of thromboxane A2 through irreversible inhibition of cyclooxygenase 1. Prasugrel and clopidogrel are irreversible inhibitors of the platelet P2Y12 ADP receptors, while ticagrelor is a reversible inhibitor of the platelet P2Y12 ADP receptor. Current guidelines recommend dual antiplatelet therapy for at least 1 month and ideally up to 1 year for patients treated medically, and at least 1 year for patients treated with DES after hospitalization for ACS.

Additionally, lipid lowering therapy is a cornerstone of post-ACS care. Multiple studies have demonstrated a direct correlation between low-density lipoprotein cholesterol (LDL-C) levels and ASCVD risk. Statins (3-hydroxy-3-methylgultaryl-coenzyme A reductase inhibitors) are first-line therapies used to achieve LDL-C reductions. High-intensity statins, such as atorvastatin 40 mg or 80 mg or rosuvastatin 20 mg or 40 mg, can lower LDL-C by > 50%, and patients with history of ACS have greater benefit from high-intensity statins versus low-intensity statins. Importantly, administration of a high-intensity statin is a Class 1 recommendation from the AHA/ACC Non-ST-Elevation ACS guidelines and the ST-Elevation ACS guidelines.

The combination of prompt diagnosis of ACS, management with coronary angiography with possible DES placement, and medical therapy including DAPT has led to improvements in ACS mortality. However, nonadherence to cardiovascular medications is common. Data from the US Veteran's Affair's hospitals show that nearly 30% of patients did not refill clopidogrel after index hospitalization for ACS. In a study of the PREMIER registry, one in seven patients stopped taking clopidogrel therapy after 1 month, and those who stopped had ninefold elevated risk of death within 1 year. Poor adherence to antiplatelet therapy with either aspirin or P2Y12 inhibitors can lead to in-stent thrombosis, a particularly morbid occurrence characterized by high patient morbidity and mortality. Early stoppage of dual antiplatelet therapy increases risk of stent thrombosis 90-fold.

Nonadherence to statins is also well documented. Roughly 1/3 of ischemic heart disease is related to dyslipidemia, and statins are the mainstay of treatment. However, roughly 25-50% of patients discontinue their statin therapy within the first year after treatment initiation. Lipid reduction is a proven strategy to prevent further cardiovascular events, however, medication nonadherence is a significant barrier.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.

排除标准

  • Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
  • Current need for inotropes or with cardiac index < 2.2 L/min/m2
  • 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 1-month study period
  • Inability to provide written informed consent

研究组 & 干预措施

Usual Care (individual medications prescribed by primary cardiologist)

Active Comparator

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.

干预措施: Usual Care (individual medications prescribed by primary cardiologist) (Drug)

Polypill

Experimental

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.

干预措施: Polypill (Drug)

结局指标

主要结局

Platelet Reactivity

时间窗: 1 month

Within-group change and between-group changes in platelet reactivity at 30 days. Platelet reactivity was assessed using impedance aggregometry (Ohms, Ω, lower = better platelet inhibition). The two relevant time points included baseline and 1 month laboratory values.

Low Density Lipoprotein - Cholesterol

时间窗: 1 month

Within group change and between-group difference, polypill vs usual care. Represented as least squares means from linear regression models adjusting for baseline values, comparing polypill strategy versus usual care. The two relevant time points included baseline and 1 month laboratory values.

次要结局

  • Quality of Life(1 month)
  • Adherence by self-report(1 month)
  • Treatment Satisfaction(1 month)
  • Adherence by Self-report(1 month)
  • Quality of Life at 1 Month(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ambarish Pandey

ASSISTANT PROFESSOR

University of Texas Southwestern Medical Center

研究点 (2)

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