Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT05032053
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-02
• Study Start: 2022-03-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2025-12-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase of cerebral microbleeds	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.

Secondary Outcome Measures

Name	Time	Method
Stroke recurrence rate	1 year after onset	recurrence rate of ischemic stroke
The incidence of cerebral hemorrhage	1 year after onset

Trial Locations

Locations (16)

Ankang Central Hospital; 🇨🇳 Ankang, Shaanxi, China

Gem Flower Xi'an Changqing Staff Hospital; 🇨🇳 Xi'an, China

Tangdu Hospital; 🇨🇳 Xi'an, China

3201 Hospital; 🇨🇳 Hanzhong, Shaanxi, China

986 Hospital; 🇨🇳 Xi'An, China

Gaoling District Hospital; 🇨🇳 Xi'an, China

The First Affiliated Hospital of Xi'an Medical University; 🇨🇳 Xi'AN, China

Xi'AN GAOXIN Hospital; 🇨🇳 Xi'AN, Shannxi, China

Yan'an University Affiliated Hospital; 🇨🇳 Ya'an, Shaanxi, China

Yulin No.2 Hospital; 🇨🇳 Yunlin, Shaanxi, China

Hanzhong People's Hospital; 🇨🇳 Hanzhong, China

No.215 Hospital of Shaanxi nuclear industry; 🇨🇳 Xianyang, China

The First People's Hospital of Xianyang; 🇨🇳 Xianyang, China

Xian Yang Central Hospital; 🇨🇳 Xianyang, China

Yan'an People's Hospital; 🇨🇳 Yan'an, China

Department of Neurology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China