Observing antithrombotic drug effects in ischemic stroke patients with microbleeds

Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

This study is testing how different blood-thinning medications affect recovery in people who have had ischemic strokes and have small brain bleeds.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 16 sites (Ankang, Shaanxi and 15 other locations)
• Trial ID: NCT05032053 on ClinicalTrials.gov

What this trial studies

This study aims to observe the effects of various antithrombotic drugs on the prognosis of patients who have experienced ischemic strokes and have cerebral microbleeds. It will involve a cohort registration study to track the progress of these patients over one year while receiving different antithrombotic therapies. Additionally, the study will utilize data independent acquisition quantitative proteomics to identify serum protein markers that may predict patient outcomes. The goal is to enhance understanding of safe and effective antithrombotic therapy for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 40 and older who have been clinically diagnosed with ischemic stroke within the last three months.

Not a fit: Patients with symptomatic intracranial hemorrhage or significant bleeding lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for ischemic stroke patients with microbleeds, potentially reducing the risk of complications.

How similar studies have performed: While the approach of using proteomics in this context is relatively novel, previous studies have indicated potential risks associated with antithrombotic drugs in similar patient populations.

Eligibility criteria

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.

Where this trial is running

Ankang, Shaanxi and 15 other locations

• Ankang Central Hospital — Ankang, Shaanxi, China (Recruiting)
• 3201 Hospital — Hanzhong, Shaanxi, China (Recruiting)
• Department of Neurology, Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)
• Yan'an University Affiliated Hospital — Ya'an, Shaanxi, China (Recruiting)
• Yulin No.2 Hospital — Yunlin, Shaanxi, China (Recruiting)
• Xi'AN GAOXIN Hospital — Xi'an, Shannxi, China (Recruiting)
• Hanzhong People's Hospital — Hanzhong, China (Recruiting)
• 986 Hospital — Xi'an, China (Recruiting)
• Gaoling District Hospital — Xi'an, China (Recruiting)
• Gem Flower Xi'an Changqing Staff Hospital — Xi'an, China (Recruiting)
• Tangdu Hospital — Xi'an, China (Recruiting)
• The First Affiliated Hospital of Xi'an Medical University — Xi'an, China (Recruiting)
• No.215 Hospital of Shaanxi nuclear industry — Xianyang, China (Recruiting)
• The First People's Hospital of Xianyang — Xianyang, China (Recruiting)
• Xian Yang Central Hospital — Xianyang, China (Recruiting)
• Yan'an People's Hospital — Yan’an, China (Recruiting)

Study contacts

• Study coordinator: Wen Jiang, Ph.D

Conditions Ischemic Stroke; microbleeds; Proteomics; antithrombotic drug