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临床试验/NCT04006288
NCT04006288已完成4 期

Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study

University of Florida1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年9月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

研究概览

简要总结

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

详细描述

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. In the COMPASS trial, patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy (DAPT) were randomized to rivaroxaban 2.5 mg bid in combination with aspirin, rivaroxaban 5 mg bid monotherapy or aspirin monotherapy. The study showed a significant 24% relative reduction in ischemic outcomes with rivaroxaban 2.5 mg bid plus aspirin combination strategy compared with aspirin alone. These observations have raised practical considerations on how to implement the results of the COMPASS trial in clinical practice particularly for patients who are completing a minimum duration of DAPT and contemplating between continuing with a DAPT regimen versus switching to a dual pathway inhibition (DPI) regimen with aspirin plus rivaroxaban. Therefore, the objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).

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

盲法说明

laboratory personnel running pharmacodynamic testing will be blinded to treatment assignment.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Aspirin and clopidogrel

Active Comparator

aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days

干预措施: Clopidogrel (Drug)

Aspirin and clopidogrel

Active Comparator

aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and clopidogrel

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and clopidogrel

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: rivaroxaban (Drug)

Aspirin and prasugrel

Active Comparator

aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days

干预措施: Prasugrel (Drug)

Aspirin and prasugrel

Active Comparator

aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and prasugrel

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and prasugrel

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: rivaroxaban (Drug)

Aspirin and ticagrelor

Active Comparator

aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days

干预措施: ticagrelor (Drug)

Aspirin and ticagrelor

Active Comparator

aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and ticagrelor

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: aspirin (Drug)

Aspirin and rivaroxaban from aspirin and ticagrelor

Experimental

aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

干预措施: rivaroxaban (Drug)

结局指标

主要结局

Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

时间窗: 30 days

The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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