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

Intracranial Hemorrhages Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03772457
• Other study ID #: InV HT RAF 1010
• Status: Recruiting
• Start date: January 18, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: 13958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant
• Atrial Fibrillation
• Cerebrovascular Stroke
• Hemorrhage
• Infarction
• Intracranial Hemorrhages
• Ischemic Stroke
• Matrix Metalloproteinases
• Stroke

Intervention

Drug:
• Rivaroxaban
new oral anticoagulant molecules which is the selective factor Xa inhibitor

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (11)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Bayer, Dongyang People's Hospital, HaiyanPeople's hospital, Jinhua Central Hospital, Rui'an People's hospital, Shaoxing People's Hospital, Taizhou Hospital, The Central Hospital of Lishui City, Wenzhou Central Hospital, Zhuji People's hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment		14 days after enrolling