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

Last updated: March 30, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Completed

Phase

N/A

Condition

Hemorrhage

Brain Injury

Stroke

Treatment

Antiplatelet Agents

Clinical Study ID

NCT04820972
HX-A-007（2021）
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-70 years old.

  • nontraumatic spontaneous intracerebral hemorrhage.

  • postoperative patients with high risk of MACCPE:(1)previous history of cerebralinfarction or TIA. (2)previous history of coronary heart disease or myocardialinfarction.(3) use ASCVD Risk EstimatorPlus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） toassess the risk of ischemic events for patients with no previous history of cerebralinfarction, TIA, or coronary heart diseases or myocardial infarction,10 yearsrisk>10% is defined as a high risk of cardiovascular ischemic events(4)The CapriniRisk Scale is used to assess the risk of venous thrombosis in the lowerextremities.Score>2 is defined as a high risk of venous thrombosis.

  • patients who received neurosurgical procedures to remove the hematoma, includingcraniotomy, 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 fellowcriteria:(1)postoperative head CT showed no new infarction orhemorrhage(2)postoperative venous ultrasound of the lower extremity did not revealdeep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzymeexamination did not show acute myocardial ischemia or myocardial infarction.

Exclusion

Exclusion Criteria:

  • there are structural cerebrovascular lesions (such as intracranial aneurysms,cerebrovascular malformations, etc.) or tumors in the area of bleeding or thebleeding 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) newanticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.

  • previous history of thrombocytopenia or coagulation disorders.

  • previous history of atrial fibrillation.

Study Design

Total Participants: 269
Treatment Group(s): 1
Primary Treatment: Antiplatelet Agents
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
May 01, 2023

Connect with a study center

  • Capital Medical University Affiliated Beijing Tiantan Hospital

    Beijing, Beijing
    China

    Site Not Available

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