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

The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: SWI sequence

Detailed Description

Cerebral microbleeds（CMBs） is a subclinical lesion caused by microvascular disease in the brain, characterized by microleakage of blood. About 30% of ischemic stroke patients, 40% of the healthy people over 80 years old, and 60% of intracranial hemorrhage patients have microbleeds. With the development of imaging technology, clinically more and more patients have found microbleeds in the brain. How these patients are treated with antithrombotic drugs is not yet clear and is in urgent need of evidence. There are only a few prospective cohort studies to determine whether antithrombotic therapy increases the risk of intracranial hemorrhage in ischemic stroke patients with CMBs, but the results are uncertain. More importantly, whether antithrombotic therapy increases the incidence of the emerging CMBs, and whether the change of increased microbleeds is associated with increased intracranial hemorrhage has not been reported.

• Study Type: Observational
• Enrollment (Estimated): 1875

Contacts and Locations

• Study Contact: Name: chen huisheng, doctor; Phone Number: 86-24-28897511; Email: chszh@aliyun.com
• Study Contact Backup: Name: wang xinhong, doctor; Phone Number: 15309885658; Email: 450341972@qq.com

Study Locations

• China
  • ShenYang, China
    • Recruiting
    • General Hospital of Shenyang Military Region
    • Contact: Cheng Xia, Ph.D; Email: xiacheng1975@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ischemic stroke patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Acute ischemic stroke patient confirmed by SWI sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	360 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cerebral bleeding events	incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI	180 days
proportion of mRS 0-1.	the minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome	180、360 days
proportion of cerebral microbleeds	cerebral microbleeds, determined by MRI	180 、360 days
proportion of cerebral hemorrhage	cerebral hemorrhage, determined by MRI	180、360 days
the occurence of stroke or other vascular events		180、360 days
the occurence of death due to any cause		180、360 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Study Director: chen huisheng, doctor, General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 17, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cerebral Hemorrhage; anti-thrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Hemorrhage; Thrombosis; Cerebral Infarction; Intracranial Hemorrhages
• Other Study ID Numbers: k(2017)33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No