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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03772457
Enrollment
400
Registered
2018-12-11
Start date
2019-01-18
Completion date
2024-12-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant, Cerebrovascular Stroke, Intracranial Hemorrhages, Matrix Metalloproteinases

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.

Interventions

DRUGRivaroxaban

new oral anticoagulant molecules which is the selective factor Xa inhibitor

Sponsors

Bayer
CollaboratorINDUSTRY
Taizhou Hospital
CollaboratorOTHER
Zhuji People's hospital
CollaboratorUNKNOWN
Shaoxing People's Hospital
CollaboratorOTHER
Jinhua Central Hospital
CollaboratorOTHER
HaiyanPeople's hospital
CollaboratorUNKNOWN
Wenzhou Central Hospital
CollaboratorOTHER
The Central Hospital of Lishui City
CollaboratorOTHER
Dongyang People's Hospital
CollaboratorOTHER
The Third Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment14 days after enrolling

Countries

China

Contacts

Primary ContactMin Lou, PhD
loumingxc@vip.sina.com13958007213

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026