Ischemic StrokeNCT03571763
The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SWI sequence
- How many people
- 1,875 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ischemic stroke patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of ShenYang Military Region
Shenyang
Cheng Xia, Ph.D, xiacheng1975@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- SWI sequence
- Keywords
- Cerebral Hemorrhage, anti-thrombosis
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWI sequenceOther
Acute ischemic stroke patient confirmed by SWI sequence
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: SWI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cerebral bleeding events
incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
Measured: 360 days
Secondary outcomes (6)
all cerebral bleeding events
incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
Measured: 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
Measured: 180、360 days
proportion of cerebral microbleeds
cerebral microbleeds, determined by MRI
Measured: 180 、360 days
proportion of cerebral hemorrhage
cerebral hemorrhage, determined by MRI
Measured: 180、360 days
the occurence of stroke or other vascular events
Measured: 180、360 days
the occurence of death due to any cause
Measured: 180、360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start1 Aug 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- chen huisheng, doctor, Study director, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571763
- Sponsor's protocol ID
- k(2017)33
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2018
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Anti-thrombosis on Cerebral Microbleeds and Intracranial Hemorrhage in Ischemic Stroke Patients: Prospective, Multi-center, Cohort Study
- ClinicalTrials.gov ID
- NCT03571763
- Acronym / sponsor ID
- k(2017)33
- Conditions
- Ischemic Stroke
- Keywords
- Cerebral Hemorrhage, anti-thrombosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,875 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke patient | – | Other: SWI sequenceacute 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ischemic stroke patients
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWI sequenceAcute ischemic stroke patient confirmed by SWI sequence | Other | acute ischemic stroke patient |
Primary outcome
all cerebral bleeding events
Time frame: 360 days
incidence of both cerebral microbleeds and intracranial hemorrhage, determined by MRI
6 secondary outcomes
all cerebral bleeding events
Time frame: 180 days
proportion of mRS 0-1.
Time frame: 180、360 days
proportion of cerebral microbleeds
Time frame: 180 、360 days
proportion of cerebral hemorrhage
Time frame: 180、360 days
the occurence of stroke or other vascular events
Time frame: 180、360 days
the occurence of death due to any cause
Time frame: 180、360 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
chen huisheng, doctor study director
General Hospital of Shenyang Military Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chen huisheng, doctor (86-24-28897511, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cerebral bleeding events (time frame: 360 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.