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

April 16, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
Time Frame: 14 days after enrolling
14 days after enrolling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Bayer
The Central Hospital of Lishui City
Shaoxing People's Hospital
Wenzhou Central Hospital
Jinhua Central Hospital
Taizhou Hospital
Zhuji People's hospital
Dongyang People's Hospital
HaiyanPeople's hospital
Rui'an People's hospital

Investigators

  • Study Chair: Min Lou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

December 9, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InV HT RAF 1010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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