Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
InV HT RAF 1010
Description
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.
Trial arms
Trial start
2019-01-18
Estimated PCD
2023-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Rivaroxaban
new oral anticoagulant molecules which is the selective factor Xa inhibitor
Size
400
Primary endpoint
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
14 days after enrolling
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

1 drug

4 indications

Organization
Second Affiliated Hospital, School of Medicine, Zhejiang University
Drug
Rivaroxaban
Indication
Cerebrovascular Stroke
Indication
Intracranial Hemorrhage
Indication
Anticoagulant
Indication
Matrix Metalloproteinases