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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04820972

Collaborator

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

250

Enrollment

Location

Arms

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Intracerebral Hemorrhage	Drug: Antiplatelet Agents	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-STAR group	Drug: Antiplatelet Agents using antiplatelet agents in 3 days after surgery
No Intervention: traditional group

Arm

Intervention/Treatment

Experimental: E-STAR group

Drug: Antiplatelet Agents

using antiplatelet agents in 3 days after surgery

No Intervention: traditional group

Outcome Measures

Primary Outcome Measures

rate of intracranial hemorrhage [7 days after surgery]
rate of intracranial hemorrhage [14 days after surgery]
rate of intracranial hemorrhage [30 days after surgery]
rate of intracranial hemorrhage [90 days after surgery]
rate of major adverse cardiac/cerebrovascular and peripheral vessel events [7 days after surgery]
rate of major adverse cardiac/cerebrovascular and peripheral vessel events [14 days after surgery]
rate of major adverse cardiac/cerebrovascular and peripheral vessel events [30 days after surgery]
rate of major adverse cardiac/cerebrovascular and peripheral vessel events [90 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.