The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients

NCT03571763 | Recruiting DMC

• 1 other identifier: k(2017)33
• Study Type: observational
• Target: 1,875
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective cohort study is to investigate whether antithrombotic therapy in the secondary prevention of ischemic stroke increases the risk of the emerging CMBs and whether the change is associated with an increased risk of intracranial hemorrhage, providing an imaging evidence for individualized antithrombotic therapy in such patients.

Conditions

Ischemic Stroke

Keywords

Cerebral Hemorrhage; anti-thrombosis

Outcome Measures

Primary Outcomes (1)

• all cerebral bleeding events

  incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI

  360 days

Secondary Outcomes (6)

• all cerebral bleeding events

  180 days

• proportion of mRS 0-1.

  180、360 days

• proportion of cerebral microbleeds

  180 、360 days

• proportion of cerebral hemorrhage

  180、360 days

• the occurence of stroke or other vascular events

  180、360 days

Study Arms (1)

acute ischemic stroke patient

acute ischemic stroke patient acute ischemic stroke patient Patient age ≥18 years .Acute ischemic stroke patient confirmed by imaging(SWI sequence) .Time of onset: within 3 months

Other: SWI sequence

Interventions

SWI sequence OTHER

Acute ischemic stroke patient confirmed by SWI sequence

acute ischemic stroke patient

Eligibility Criteria

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

Study Population

ischemic stroke patients

You may qualify if:

• Patient age ≥18 years;
• Acute ischemic stroke patient confirmed by imaging;
• Time of onset: within 3 months;
• Baseline SWI sequence is completed before starting the secondary prevention of ischemic stroke;
• Baseline SWI sequence must have at least one CMB ;
• NIHSS≤10

You may not qualify if:

• MRI contraindication;
• Hemorrhagic transformation after acute Ischemic stroke;
• Contraindication for antiplatelet or anticoagulation therapy;
• Severe head trauma or intracranial hemorrhage occurred in the past six months;
• obvious coagulopathy;
• Other intracranial lesions associated with (such as tumor, cerebral vascular malformation);
• other unqualified patients judged by the investigator

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• chen huisheng, doctor

  General Hospital of Shenyang Military Region

  STUDY DIRECTOR

Central Study Contacts

chen huisheng, doctor

CONTACT

86-24-28897511; chszh@aliyun.com

wang xinhong, doctor

CONTACT

15309885658; 450341972@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of neurological department

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 28, 2018
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)