Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage

Not Applicable

Completed

• Conditions: Spontaneous Intracerebral Hemorrhage
• Interventions: Drug: Antiplatelet Agents

• Registration Number: NCT04820972
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-05-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• 18-70 years old.
• nontraumatic spontaneous intracerebral hemorrhage.
• postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score>2 is defined as a high risk of venous thrombosis.
• patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration.
• patients who signed informed consent.
• no history of allergy to salicylic acid preparation.
• patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head CT showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction.

Exclusion Criteria

• there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions.
• ischemic stroke with hemorrhagic conversion.
• secondary bleeding due to venous embolism.
• the malignant tumor is expected to have a survival of no more than 3 months.
• take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.
• previous history of thrombocytopenia or coagulation disorders.
• previous history of atrial fibrillation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-STAR group	Antiplatelet Agents	-

Primary Outcome Measures

Name	Time	Method
rate of intracranial hemorrhage	90 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events	90 days after surgery

Trial Locations

Locations (1)

Capital Medical University Affiliated Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China