CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
Rivaroxaban 2.5 mg Tabletdrug
Likely dose
Rivaroxaban 2.5 mg Tabletfrom 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/NCT03718429
NCT03718429Phase 4Completed

Pharmacodynamic Effects of Low-dose Rivaroxaban in Combination With Antiplatelet Therapies in Patients With Coronary and Peripheral Artery Disease Manifestations

University of Florida·interventional·Posted Oct 24, 2018·Updated Jun 27, 2022

In Brief

A Phase 4 clinical trial evaluating Rivaroxaban 2.5 mg Tablet for Coronary Artery Disease and 2 related conditions. Completed, enrolled 86 participants across 2 sites.

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. To date there is very little data, and not conducted in human subjects, on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies, and in particular how this affects profiles of platelet reactivity and thrombin generation. Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations, including coronary artery disease (CAD) and peripheral arterial disease (PAD), the study team proposes a prospective pharmacodynamic (PD) investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 24, 2018
Enrollment StartJan 14, 2019
Primary CompletionFeb 13, 2020
Study CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.7 years ago

Interventions

Rivaroxaban 2.5 mg Tabletdrug

PD assessments will be conducted at 3 time points: i) baseline (while on standard of care antiplatelet therapy), ii) 7-10 days after adjunctive treatment with low dose rivaroxaban, and iii) 7-10 days after dropping aspirin.