Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
NCT ID: NCT04820972
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
269 participants
INTERVENTIONAL
2021-05-01
2023-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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E-STAR group
Antiplatelet Agents
using antiplatelet agents in 3 days after surgery
traditional group
No interventions assigned to this group
Interventions
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Antiplatelet Agents
using antiplatelet agents in 3 days after surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Kunming Medical University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Second Xiangya Hospital of Central South University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Gangzhou Red Cross Hospital ,Jinan University
UNKNOWN
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
UNKNOWN
Beijing Friendship Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Principal Investigators
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Shuo Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Liu Q, Mo S, Wu J, Tong X, Wang K, Chen X, Chen S, Guo S, Li X, Li M, Peng L, Sun X, Wang Y, Sun J, Pu J, Zheng K, Zhang J, Liu Y, Yang Y, Wen Z, Nie X, Feng Y, Lan C, Tang H, Wang N, Li J, Miao Z, Lu X, Ning B, Zhao B, Kang D, Chen X, Zhang Y, Zhang Y, Wang A, Zhu C, Araki Y, Uda K, Yoshimura S, Uchida K, Morimoto T, Yoshioka H, Hasan D, Du R, Levitt MR, Cao Y, Wang S, Zhao J; E-start collaborators. Safety and efficacy of early versus delayed acetylsalicylic acid after surgery for spontaneous intracerebral haemorrhage in China (E-start): a prospective, multicentre, open-label, blinded-endpoint, randomised trial. Lancet Neurol. 2024 Dec;23(12):1195-1204. doi: 10.1016/S1474-4422(24)00424-1.
Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
Wang K, Mo S, Liu Q, Pu J, Huang X, Kang D, Lin F, Zou D, Sun X, Ren J, Tong X, Li J, Salman RA, Wang N, Guo S, Liu Y, Zhang Y, Li X, Wu J, Wang S. Early-start antiplatelet therapy after operation in patients with spontaneous intracerebral hemorrhage and high risk of ischemic events (E-start): Protocol for a multi-centered, prospective, open-label, blinded endpoint randomized controlled trial. Front Aging Neurosci. 2022 Nov 23;14:1020224. doi: 10.3389/fnagi.2022.1020224. eCollection 2022.
Other Identifiers
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HX-A-007(2021)
Identifier Type: -
Identifier Source: org_study_id
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