Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds (AIM-2)

April 3, 2023 updated by: Xijing Hospital
To observe the effect of different antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds. And further combined with proteomic methods to explore serological markers that can be used to accurately predict the prognosis of such patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebral microbleeds (CMBs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. Studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe antithrombotic therapy is still unclear.

We will study from two aspects: 1) We designed a cohort registration study to observe the prognosis and progress of CMBs in ischemic stroke patients one year after using various antithrombotic drugs. 2) Data independent acquisition quantitative proteomics (DIA quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with CMBs.

Study Type

Observational

Enrollment (Anticipated)

3000

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 Locations

  • China
      • Hanzhong, China
        • Recruiting
        • Hanzhong People's Hospital
        • Contact:
          • Chunrui Zhang
      • Xi'AN, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Medical University
      • Xi'An, China
        • Recruiting
        • 986 Hospital
        • Contact:
          • Liyi Chi
      • Xi'an, China
        • Recruiting
        • Gaoling District Hospital
        • Contact:
          • Ning Min
      • Xi'an, China
        • Recruiting
        • Gem Flower Xi'an Changqing Staff Hospital
        • Contact:
          • Chaofeng Zhang
      • Xi'an, China
        • Recruiting
        • Tangdu Hospital
      • Xianyang, China
        • Recruiting
        • No.215 Hospital of Shaanxi nuclear industry
        • Contact:
          • Feng Fu
      • Xianyang, China
        • Recruiting
        • The First People's Hospital of Xianyang
        • Contact:
          • Liping Yu
      • Xianyang, China
        • Recruiting
        • Xian Yang Central Hospital
        • Contact:
          • Jun Wu
      • Yan'an, China
        • Recruiting
        • Yan'an People's Hospital
        • Contact:
          • Baiya Fan
    • Shaanxi
      • Ankang, Shaanxi, China, 725000
        • Recruiting
        • Ankang Central Hospital
        • Contact:
          • Xiai Yang, MD
        • Principal Investigator:
          • Xiai Yang, MD
      • Hanzhong, Shaanxi, China
        • Recruiting
        • 3201 Hospital
        • Contact:
          • Hua Li
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Neurology, Xijing Hospital, Fourth Military Medical University
        • Contact:
      • Ya'an, Shaanxi, China
        • Recruiting
        • Yan'an University Affiliated Hospital
        • Contact:
          • Yidong Xue
      • Yunlin, Shaanxi, China, 719000
        • Recruiting
        • Yulin No.2 Hospital
        • Contact:
          • Xiaocheng Wang, MD
        • Principal Investigator:
          • Xiaocheng Wang, MD
    • Shannxi
      • Xi'AN, Shannxi, China, 710032
        • Recruiting
        • Xi'an Gaoxin Hospital
        • Contact:
          • Yi Jia
          • Phone Number: 13659283392

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population we observed are hospitalized patients with new cerebral infarction and met the inclusion criteria(without exclusion criteria). The method of consecutive participant sampling is used to collect the included population.

Description

Inclusion Criteria:

  1. Patients diagnosed clinically as ischemic stroke;
  2. Age ≥ 40 years;
  3. Onset time ≤ 3 months;
  4. Informed consent was signed.

Exclusion Criteria:

  1. Patients with symptomatic intracranial hemorrhage;
  2. bleeding lesion > 10 mm was found on SWI;
  3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
  4. There are contraindications for antithrombotic drugs use;
  5. Serious systemic diseases;
  6. Refusal to sign informed consent or poor compliance.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of cerebral microbleeds
Time Frame: 1 year after onset
How many cerebral microbleeds increased after 1 year of antithrombotic drugs treatment. The number of microbleeds will be detected by MR-SWI.
1 year after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke recurrence rate
Time Frame: 1 year after onset
recurrence rate of ischemic stroke
1 year after onset
The incidence of cerebral hemorrhage
Time Frame: 1 year after onset
1 year after onset

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Collaborators

Ankang Central Hospital
Yan'an University Affiliated Hospital

Investigators

  • Study Director: Wen Jiang, Ph.D, Department of Neurology, Xijing Hospital, Fourth Military Medical University

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 (Actual)

March 1, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

October 1, 2026

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJLL-KY20212114

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

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.

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