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

NCT ID: NCT04820972

Last Updated: 2025-04-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-05-01

Brief Summary

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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

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Conditions

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Spontaneous Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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E-STAR group

Group Type EXPERIMENTAL

Antiplatelet Agents

Intervention Type DRUG

using antiplatelet agents in 3 days after surgery

traditional group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antiplatelet Agents

using antiplatelet agents in 3 days after surgery

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Gangzhou Red Cross Hospital ,Jinan University

UNKNOWN

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Sichuan Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Chongqing General Hospital

OTHER

Sponsor Role collaborator

Binzhou Medical University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Shanxi Provincial People Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 39577920 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36700520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36506468 (View on PubMed)

Other Identifiers

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HX-A-007(2021)

Identifier Type: -

Identifier Source: org_study_id

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