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

NCT03772457 | Unknown DMC FDA Drug

• 1 other identifier: InV HT RAF 1010
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Stroke; Intracranial Hemorrhages; Anticoagulant; Matrix Metalloproteinases

Outcome Measures

Primary Outcomes (1)

• Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment

  14 days after enrolling

Interventions

Rivaroxaban DRUG

new oral anticoagulant molecules which is the selective factor Xa inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and receiveRivaroxaban treatment in the in-patient ward.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Bayer: collaborator
• Taizhou Hospital: collaborator
• Zhuji People's hospital: collaborator
• Shaoxing People's Hospital: collaborator
• Jinhua Central Hospital: collaborator
• HaiyanPeople's hospital: collaborator
• Wenzhou Central Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Dongyang People's Hospital: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke; Intracranial Hemorrhages

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Min Lou, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Min Lou, PhD

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: December 11, 2018
• Study Start: January 18, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)