Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Prasugrel; Drug: ticagrelor; Drug: Clopidogrel; Drug: aspirin; Drug: rivaroxaban

• Registration Number: NCT04006288
• Lead Sponsor: University of Florida

Brief Summary

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).

Detailed Description

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).

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Study Start: 2019-09-06
• Primary Completion: 2022-01-31
• Study Completion: 2022-05-16
• Results First Submitted: 2023-03-30
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Results First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin and prasugrel	Prasugrel	aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Aspirin and ticagrelor	ticagrelor	aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
Aspirin and ticagrelor	aspirin	aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
Aspirin and prasugrel	aspirin	aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
Aspirin and clopidogrel	aspirin	aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Aspirin and clopidogrel	Clopidogrel	aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
Aspirin and rivaroxaban from aspirin and clopidogrel	aspirin	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and clopidogrel	rivaroxaban	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and prasugrel	rivaroxaban	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and prasugrel	aspirin	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and ticagrelor	aspirin	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
Aspirin and rivaroxaban from aspirin and ticagrelor	rivaroxaban	aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States