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Anticoagulation Using Rivaroxaban on Top of Aspirin in Intracranial Atherosclerotic Stenosis

NCT05700266 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2023-12-21

No results posted yet for this study

Summary

The primary goal of the clinical trial is to test the effect of oral rivaroxaban plus aspirin in patients with recent stroke/ transient ischemic attack (TIA) caused by intracranial artery stenosis. Participants will be divided into 2 groups to receive either oral rivaroxaban plus aspirin or oral clopidogrel plus aspirin. The main question it aims to answer is whether the experimental group (oral rivaroxaban plus aspirin) is superior to the control group ( oral clopidogrel plus aspirin) to lower recurrent stroke/TIA or death in these patients during 1 year of follow-up.

Conditions

Interventions

DRUG

Rivaroxaban

Rivaroxaban (2.5mg orally twice a day for 90 days)

DRUG

Clopidogrel

Clopidogrel (300mg loading dose, then 75mg once daily for 90 days)

DRUG

Aspirin

Aspirin (100mg once a day for 1 year)

OTHER

Risk Factor Management in both arms

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

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Kezhong Zhang, Doctor · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-30
Primary Completion
2024-12-31
Completion
2024-12-31

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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 NCT05700266 on ClinicalTrials.gov