Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Recruiting

• Conditions: Intracranial Hemorrhages; Cerebrovascular Stroke; Anticoagulant; Matrix Metalloproteinases

• Registration Number: NCT03772457
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-11
• Study Start: 2019-01-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male or female, age≥18;
2. Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
3. Prescribedand accept Rivaroxaban;
4. Sign thewritten informed consent.

Exclusion Criteria

1. Renal impairment (CrCl<15 ml/min) or severe hepatic impairment.
2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
3. Stroke or TIA caused by large artery atherosclerosis
4. Planned major surgery or invasive intervention
5. Active internal bleeding
6. Malignancy or other serious medical conditions with a life expectancy <6 months
7. Allergery to Rivaroxaban
8. Pregnancy or breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment	14 days after enrolling

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China