Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03571763

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of ShenYang Military Region

Shenyang, China

Location status: Recruiting

Location contact

Cheng Xia, Ph.D

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SWI sequence

Other

Acute ischemic stroke patient confirmed by SWI sequence

Primary outcomes

  1. all cerebral bleeding events

    Time frame: 360 days

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

Secondary outcomes

  1. all cerebral bleeding events

    Time frame: 180 days

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

  2. proportion of mRS 0-1.

    Time frame: 180、360 days

    the minimum and maximum values of modified Rankin Score (mRS) are 0 and 6, respectively; higher score mean a worse outcome

  3. proportion of cerebral microbleeds

    Time frame: 180 、360 days

    cerebral microbleeds, determined by MRI

  4. proportion of cerebral hemorrhage

    Time frame: 180、360 days

    cerebral hemorrhage, determined by MRI

  5. the occurence of stroke or other vascular events

    Time frame: 180、360 days

  6. the occurence of death due to any cause

    Time frame: 180、360 days

Study contacts

Contact information is provided by the study sponsor or research team.

chen huisheng, doctor

CONTACT

[email protected]

86-24-28897511

wang xinhong, doctor

CONTACT

[email protected]

15309885658

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2018
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.