Predictive Value of Infarction Volume on Hemorrhagic Tran... | NCT03772457

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

NCT03772457

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Cerebrovascular Stroke
Intracranial Hemorrhages
Anticoagulant
Matrix Metalloproteinases

Interventions

Rivaroxaban

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2019Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 10, 2017

First Submission Date that Met QC Criteria

Dec 9, 2018

First Posted Date

Dec 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2023

Last Update Posted Date

Apr 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Name	Class
Bayer	INDUSTRY
Taizhou Hospital	OTHER
Zhuji People's Hospital of Zhejiang Province	OTHER
Shaoxing People's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	new oral anticoagulant molecules which is the selective factor Xa inhibitor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Lou, PhD	Contact	13958007213		loumingxc@vip.sina.com

Overall Officials

Name	Affiliation	Role
Min Lou, PhD	Second Affiliated Hospital, School of Medicine, Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D020300	Intracranial Hemorrhages

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds