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NCT Number: NCT04820972

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

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.

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Key information

Conditions

Spontaneous Intracerebral Hemorrhage

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antiplatelet Agents

Drug

using antiplatelet agents in 3 days after surgery

Primary outcomes

  1. rate of intracranial hemorrhage

    Time frame: 7 days after surgery

  2. rate of intracranial hemorrhage

    Time frame: 14 days after surgery

  3. rate of intracranial hemorrhage

    Time frame: 30 days after surgery

  4. rate of intracranial hemorrhage

    Time frame: 90 days after surgery

  5. rate of major adverse cardiac/cerebrovascular and peripheral vessel events

    Time frame: 7 days after surgery

  6. rate of major adverse cardiac/cerebrovascular and peripheral vessel events

    Time frame: 14 days after surgery

  7. rate of major adverse cardiac/cerebrovascular and peripheral vessel events

    Time frame: 30 days after surgery

  8. rate of major adverse cardiac/cerebrovascular and peripheral vessel events

    Time frame: 90 days after surgery

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital
  • Binzhou Medical University
  • Chongqing General Hospital
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Harbin Medical University
  • Fujian Medical University Union Hospital
  • Gangzhou Red Cross Hospital ，Jinan University
  • Qilu Hospital of Shandong University
  • RenJi Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Second Xiangya Hospital of Central South University
  • Shanxi Provincial People's Hospital
  • Sichuan Academy of Medical Sciences
  • The Second Affiliated Hospital of Kunming Medical University

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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