NCT05009862

The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease.

Detailed description

The Primary Investigator's central hypothesis is that activation of thrombotic pathways and downstream effectors of factor Xa signaling contribute to the development of PAD and its complications. Aim 1: To assess the impact of rivaroxaban on macrovascular endothelial function in a randomized, double-blind, placebo-controlled crossover intervention in humans with PAD. Aim 2: To assess the impact of rivaroxaban on PAR-1-mediated platelet activation in addition to its pleiotropic effects on thrombosis, thrombolysis, and inflammation in a randomized, double-blind, placebo-controlled crossover intervention in humans with PAD.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 Mg Oral Tablet	rivaroxaban 2.5 milligrams twice daily
DRUG	Placebo	placebo
DRUG	Aspirin 81Mg Ec Tab	aspirin 81 milligrams

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-08-18
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study