MedTrace Logo

Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies

NCT03718429 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-06-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Rivaroxaban 2.5 mg Tablet

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.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Dominick J Angiolillo, MD,PhD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2020-02-13
Completion
2020-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718429 on ClinicalTrials.gov