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Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds (AIM)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
low-dose aspirin
conventional-does aspirin
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, microbleeds, Clinical trial, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke;
  2. Age ≥ 18 years;
  3. Onset time ≤ 3 weeks;
  4. At least one cerebral microbleeds lesion was found on SWI;
  5. Informed consent was signed.

Exclusion Criteria:

  1. Patients with symptomatic intracranial hemorrhage;
  2. No microbleeds or bleeding lesion > 10 mm was found on SWI;
  3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
  4. Clear anticoagulant indications (such as atrial fibrillation);
  5. There are contraindications for aspirin use;
  6. The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy;
  7. Patients with coronary heart disease or other diseases need to take antiplatelet drugs;
  8. Serious systemic diseases;
  9. Refusal to sign informed consent or poor compliance.

Sites / Locations

  • Baoji Central HospitalRecruiting
  • Department of Neurology, Xijing Hospital, Fourth Military Medical UniversityRecruiting
  • Tangdu HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Medical UniversityRecruiting
  • Xi'an Central HospitalRecruiting
  • Xianyang Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low-dose aspirin

conventional-does aspirin

Arm Description

Management policy is to use 50 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 50mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke. But this dose is rarely used clinically, especially in East Asia area.

Management policy is to use 100 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 100mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke, and this dose is widely used clinically.

Outcomes

Primary Outcome Measures

Increase of cerebral microbleeds
How many cerebral microbleeds increased after 6 months of aspirin treatment. Cerebral microbleeds will be detected by MR-SWI in the acute stage and 6 months after the onset of stroke.

Secondary Outcome Measures

Stroke recurrence rate
recurrence rate of ischemic stroke
The incidence of cerebral hemorrhage

Full Information

First Posted
August 5, 2020
Last Updated
February 7, 2022
Sponsor
Xijing Hospital
Collaborators
Shaanxi Provincial People's Hospital, The First Affiliated Hospital of Jiaotong University, Tang-Du Hospital, The First Affiliated Hospital of Xi'an Medical University, Xi'an Central Hospital, Xiangyang Central Hospital, Baoji Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04504864
Brief Title
Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds
Acronym
AIM
Official Title
Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Shaanxi Provincial People's Hospital, The First Affiliated Hospital of Jiaotong University, Tang-Du Hospital, The First Affiliated Hospital of Xi'an Medical University, Xi'an Central Hospital, Xiangyang Central Hospital, Baoji Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and efficacy of low-dose (50mg) aspirin as a secondary prevention drug in patients with Non-Cardioembolic Ischemic Stroke accompanied by cerebral microbleeds.
Detailed Description
Cerebral microbleeds are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Aspirin is the most widely used anti-thrombotic drug in the secondary prevention of patients with non-cardioembolic ischemic stroke. Studies have shown that conventional doses of aspirin can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe anti-thrombotic therapy is still unclear. The AIM study aims to provide reliable data on the effects of low-dose Aspirin (50mg target recruitment 200) in patients with non-cardioembolic ischemic stroke and cerebral microbleeds compared to conventional dose (100mg target recruitment 200). Patients presenting with acute (<3 weeks) non-cardioembolic ischemic stroke and microbleeds (≧1 microbleeds in SWI scans) will be randomly assigned to the secondary stroke prevention therapy of low-dose or conventional dose aspirin for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic Stroke, microbleeds, Clinical trial, Aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-dose aspirin
Arm Type
Experimental
Arm Description
Management policy is to use 50 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 50mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke. But this dose is rarely used clinically, especially in East Asia area.
Arm Title
conventional-does aspirin
Arm Type
Active Comparator
Arm Description
Management policy is to use 100 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 100mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke, and this dose is widely used clinically.
Intervention Type
Drug
Intervention Name(s)
low-dose aspirin
Intervention Description
50mg aspirin is used to prevent recurrent stroke.
Intervention Type
Drug
Intervention Name(s)
conventional-does aspirin
Intervention Description
100mg aspirin is used to prevent recurrent stroke.
Primary Outcome Measure Information:
Title
Increase of cerebral microbleeds
Description
How many cerebral microbleeds increased after 6 months of aspirin treatment. Cerebral microbleeds will be detected by MR-SWI in the acute stage and 6 months after the onset of stroke.
Time Frame
6 months after onset
Secondary Outcome Measure Information:
Title
Stroke recurrence rate
Description
recurrence rate of ischemic stroke
Time Frame
6 months after onset
Title
The incidence of cerebral hemorrhage
Time Frame
6 months after onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke; Age ≥ 18 years; Onset time ≤ 3 weeks; At least one cerebral microbleeds lesion was found on SWI; Informed consent was signed. Exclusion Criteria: Patients with symptomatic intracranial hemorrhage; No microbleeds or bleeding lesion > 10 mm was found on SWI; Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present; Clear anticoagulant indications (such as atrial fibrillation); There are contraindications for aspirin use; The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy; Patients with coronary heart disease or other diseases need to take antiplatelet drugs; Serious systemic diseases; Refusal to sign informed consent or poor compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Jiang, Ph.D
Phone
86-029-84771319
Email
jiangwen@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yang, Ph.D
Phone
86-029-84771319
Email
fyangx@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Jiang, Ph.D
Organizational Affiliation
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Baoji Central Hospital
City
Baoji
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Luo, MD
Email
amosluo@126.com
Facility Name
Department of Neurology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Jiang, PhD
Phone
86-029-84771319
Email
jiangwen@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Fang Yang, PhD
Phone
86-029-84771319
Email
fyangx@fmmu.edu.cn
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Guo
Email
1443291624@qq.com
First Name & Middle Initial & Last Name & Degree
Wei Zhang, MD
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijun Zhang, MD
Email
155114434@qq.com
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqin Liu, MD
Email
docterqing@163.com
Facility Name
Xianyang Central Hospital
City
Xianyang
State/Province
Shaanxi
ZIP/Postal Code
712000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Han, MD
Phone
+8615399259050
First Name & Middle Initial & Last Name & Degree
Changhu Xue, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds

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