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Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis

NCT05047172 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1683

Last updated 2026-05-22

No results posted yet for this study

Summary

The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.

Conditions

  • Intracranial Arteriosclerosis
  • Stroke

Interventions

DRUG

Ticagrelor + Aspirin

ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)

DRUG

Rivaroxaban + Aspirin

low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)

DRUG

Clopidogrel + Aspirin

clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)

OTHER

Risk Factor Management

Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Cincinnati

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Brian L. Hoh, MD, MBA · University of Florida

  • Marc I. Chimowitz, MBChB · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05047172 on ClinicalTrials.gov