Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772457
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease Intervention/treatment
Cerebrovascular Stroke Intracranial Hemorrhages Anticoagulant Matrix Metalloproteinases Drug: Rivaroxaban

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban


Intervention Details:
  • Drug: Rivaroxaban
    new oral anticoagulant molecules which is the selective factor Xa inhibitor


Primary Outcome Measures :
  1. Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment [ Time Frame: 14 days after enrolling ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772457


Contacts
Layout table for location contacts
Contact: Min Lou, PhD 13958007213 loumingxc@vip.sina.com

Locations
Layout table for location information
China, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: MIN LOU, Ph.D.    8657187784811    loumingxc@vip.sina.com   
Principal Investigator: MIN LOU, Ph.D.         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Bayer
Investigators
Layout table for investigator information
Study Chair: Min Lou, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
Layout table for additonal information
Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03772457    
Other Study ID Numbers: InV HT RAF 1010
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Intracranial Hemorrhages
Atrial Fibrillation
Infarction
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Ischemia
Necrosis
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants