CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Clopidogrel +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04006288
NCT04006288Phase 4Completed

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 Florida·interventional·Posted Jul 5, 2019·Updated Apr 26, 2023

In Brief

A Phase 4 clinical trial evaluating Clopidogrel, Prasugrel, and 3 other interventions for Coronary Artery Disease. Completed, enrolled 90 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsJanssen, LP

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartSep 6, 2019
Primary CompletionJan 31, 2022
Study CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.0 years ago

Interventions

Clopidogreldrug

Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban

Prasugreldrug

Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban

ticagrelordrug

Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban

aspirindrug

all patients will remain on aspirin

rivaroxabandrug

Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban