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

Primary Purpose

Spontaneous Intracerebral Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antiplatelet Agents
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spontaneous Intracerebral Hemorrhage focused on measuring antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Capital Medical University Affiliated Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

E-STAR group

traditional group

Arm Description

Outcomes

Primary Outcome Measures

rate of intracranial hemorrhage
rate of intracranial hemorrhage
rate of intracranial hemorrhage
rate of intracranial hemorrhage
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
rate of major adverse cardiac/cerebrovascular and peripheral vessel events

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
February 23, 2022
Sponsor
Beijing Tiantan Hospital
Collaborators
The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Fujian Medical University, The Second Xiangya Hospital of Central South Medical University, First Affiliated Hospital of Harbin Medical University, Gangzhou Red Cross Hospital ，Jinan University, Beijing Chao Yang Hospital, RenJi Hospital, Sichuan Academy of Medical Sciences, Chongqing General Hospital, Binzhou Medical University, Fujian Medical University Union Hospital, Shanxi Provincial People Hospital, Beijing Friendship Hospital, Qilu Hospital of Shandong University, Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04820972
Brief Title
Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
Official Title
Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Fujian Medical University, The Second Xiangya Hospital of Central South Medical University, First Affiliated Hospital of Harbin Medical University, Gangzhou Red Cross Hospital ，Jinan University, Beijing Chao Yang Hospital, RenJi Hospital, Sichuan Academy of Medical Sciences, Chongqing General Hospital, Binzhou Medical University, Fujian Medical University Union Hospital, Shanxi Provincial People Hospital, Beijing Friendship Hospital, Qilu Hospital of Shandong University, Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Intracerebral Hemorrhage
Keywords
antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-STAR group
Arm Type
Experimental
Arm Title
traditional group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Agents
Intervention Description
using antiplatelet agents in 3 days after surgery
Primary Outcome Measure Information:
Title
rate of intracranial hemorrhage
Time Frame
7 days after surgery
Title
rate of intracranial hemorrhage
Time Frame
14 days after surgery
Title
rate of intracranial hemorrhage
Time Frame
30 days after surgery
Title
rate of intracranial hemorrhage
Time Frame
90 days after surgery
Title
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time Frame
7 days after surgery
Title
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time Frame
14 days after surgery
Title
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time Frame
30 days after surgery
Title
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time Frame
90 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUN WU, MD
Phone
+8613426322945
Email
wujunslf@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Wang, MD
Phone
13801180330
Email
captain9858@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Medical University Affiliated Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUN WU, MD
Phone
+8613426322945
Email
wujunslf@126.com
First Name & Middle Initial & Last Name & Degree
Shuo Wang, MD

12. IPD Sharing Statement

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

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