Antiplatelet Therapy for Silent Brain Infarction (ANTISBI)

October 24, 2017 updated by: Dr. Yi Sui, First People's Hospital of Shenyang

Antiplatelet Therapy in Secondary Prevention for Patient With Silent Brain Infarction

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing evidence with regard to the preventive efficacy of antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if antiplatelet therapy can effectively decrease the incidence of future stroke in SBI individuals.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

SBI is defined as a focal hyperintense lesion on T2-weighted images and/or fluid-attenuated inversion recovery with no corresponding symptoms in the clinical history of the patient that could be attributed to the lesion. SBI were distinguished from nonspecific subcortical and periventricular white matter lesions by the presence of a corresponding hypointense lesion on T1-weighted images.

The prevalence of SBI varies from 5% to 62% in healthy population. To date, few studies investigate the association between SBI and ethnicity. The effectiveness of antithrombotics including aspirin against future symptomatic stroke in SBI patients remains to be established. Due to the high prevalence of ICAS among Chinese, and its nature of artery-to-artery microembolisms, investigators hypothesize that the prevalence of SBI among Chinese might be significantly higher than other races such as Caucasians and African-Americans.

Recent study has revealed that SBI is associated with an 2-fold increase of future ischemic stroke. Yet, interventions such as antiplatelet therapies for reducing the stroke risk in SBI patients have not been investigated to our best knowledge. In this study, investigators examine whether regular oral aspirin can reduce the incidence of cerebrovascular events and mortality in SBI patients.

Study Type

Interventional

Enrollment (Anticipated)

3400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110041
        • Shenyang Brain Hsopital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yi Sui, MD PhD
        • Sub-Investigator:
          • Bing Xu, MD PhD
        • Sub-Investigator:
          • Jin Zhou, MD PhD
        • Sub-Investigator:
          • Li Li, MD PhD
        • Sub-Investigator:
          • Ying Xiao, MD MMed
        • Sub-Investigator:
          • Li Ren, MD MMed
        • Sub-Investigator:
          • Yunxin Zhai, MD MMed
        • Sub-Investigator:
          • Xu Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cerebral infarction(s) identified by CT/MRI (≥ 3mm in diameter)
  • absence of signs or symptoms of neurological dysfunction ascribed to the lesion(s)
  • absence of PMH of neurological dysfunctions due to CNS lesion(s)

Exclusion Criteria:

  • Age under 45 years or above 80 years
  • PMH of ICH within 180 days
  • PMH of lobar hemorrhage of anytime
  • Neuroimaging evidence suggesting cerebral microbleeds
  • High risk of bleeding (e.g. recurrent gastrointestinal or genitourinary bleeding, active peptic ulcer disease)
  • Anticipated requirement for long-term use (more than 28 days) of anticoagulants (e.g. recurrent deep vein thrombosis)
  • Prior long-term use of anticoagulants (more than 28 days) or antiplatelet agents (more than 28 days)
  • Prior retinal stroke/TIA (diagnosed either clinically or by imaging)
  • Intolerance or contraindications to aspirin (including thrombocytopenia, prolonged INR)
  • Prior ipsilateral carotid endarterectomy/stent
  • Stenosis of culprit artery ≥ 70% (detected by ultrasound, MRA, CTA or DSA)
  • Atrial fibrillation, or acute myocardial infarction, or acute congestive heart failure
  • Impaired renal function: glomerular filtration rate<60
  • Mini Mental Status Examination score<24 (adjusted for age and education)
  • Medical contraindication to MRI
  • Pregnancy or women of child-bearing potential who are not following an effective method of contraception
  • Unable or unwilling to provide informed consent
  • Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
  • Patients concurrently participating in another study with an investigational drug or device
  • Independence ascribed to limb deformity or prior disability
  • Acute myocardial infarction
  • Acute congestive heart failure
  • Other anticipated reasons for future application of antiplatelet agents other than aspirin (eg. recent stenting, interventional surgeries, Lower-Extremity Atherosclerotic Arterial Disease etc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aspirin 100mg
Participants will be given aspirin 100mg once per day.
Drug: Aspirin
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
Other Names:
  • Bayaspirin
Placebo Comparator: placebo
Participants will be given placebo oral tablets once per day.
Drug: Placebo Oral Tablet
Placebo resembling aspirin tablet will be be given to participants in control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite outcome with any incident stroke, myocardial infarction and all-cause death
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Shenyang

Investigators

  • Principal Investigator: Yi Sui, MD PhD, First People's Hospital of Shenyang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstPHShenyang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Infarction

Clinical Trials on Aspirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe