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

NCT ID: NCT03772457

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-18

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Cerebrovascular Stroke Intracranial Hemorrhages Anticoagulant Matrix Metalloproteinases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rivaroxaban

new oral anticoagulant molecules which is the selective factor Xa inhibitor

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Zhuji People's hospital

UNKNOWN

Sponsor Role collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

HaiyanPeople's hospital

UNKNOWN

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Lou, PhD

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lou, PhD

Role: CONTACT

13958007213

Facility Contacts

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MIN LOU, Ph.D.

Role: primary

8657187784811

Other Identifiers

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InV HT RAF 1010

Identifier Type: -

Identifier Source: org_study_id

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