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Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Primary Purpose

Cerebrovascular Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Desirable TEG
Undesirable TEG
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrovascular Disease focused on measuring antithrombotic therapy

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 14 years of age or older
  • no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients
  • The researcher (or principal) signs the informed consent form

Exclusion Criteria:

  • Significant head trauma or stroke in the last 3 months
  • 3 months to accept intracranial, spinal surgery or other parts of large surgery
  • In the last week there is an incurable part of the artery puncture
  • Acute bleeding constitution, including platelet count <100 × 109 / L or other conditions
  • within the last 48h heparin treatment, APTT higher than the upper limit of normal range
  • Oral anticoagulant: INR> 1.7 or PT> 15s
  • The presence of intracranial tumors, aneurysms or arteriovenous malformations
  • Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator)
  • Severe liver and kidney dysfunction
  • Life expectancy is less than 1 year
  • Pregnant or lactating women
  • Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research
  • Allergic or intolerant to aspirin or clopidogrel
  • There are stomach lesions, such as gastritis, gastric ulcer and so on
  • Do not want to follow-up or poor treatment compliance

Sites / Locations

  • XuanWu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Desirable TEG

Undesirable TEG

Arm Description

Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.

Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.

Outcomes

Primary Outcome Measures

Efficient Aspirin
The value of inhibition rate of Aspirin > 50%

Secondary Outcome Measures

Efficient Clopidogrel
The value of adenosine diphosphate> 30%

Full Information

First Posted
December 5, 2017
Last Updated
March 13, 2018
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Chinese PLA General Hospital, Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03471169
Brief Title
Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease
Official Title
Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Chinese PLA General Hospital, Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.
Detailed Description
Ischemic stroke is a leading cause of disability and death worldwide. Antiplatelet treatment is one of treatment strategies in secondary stroke prevention for patients with non-cardioemoblism etiology. However, a concerning issue is that wide interindividual variability in P2Y12 antagonist, especially clopidogrel. The rate on-treatment high platelet reactivity (HPR) can be as high as in one-third of patients with standard dose of clopidogrel( i.e. 75mg), and HPR has been noted in those who received other P2Y12 antagonists, such as ticagrelor and prasugrel. In the present study, we aimed to investigate the safety and potential therapeutic effect of individualized treatment of antiplatelet in secondary prevention in a cohort of patients with non-cardioembolic ischemic strokes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease
Keywords
antithrombotic therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desirable TEG
Arm Type
Experimental
Arm Description
Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.
Arm Title
Undesirable TEG
Arm Type
Sham Comparator
Arm Description
Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.
Intervention Type
Drug
Intervention Name(s)
Desirable TEG
Other Intervention Name(s)
blood sampling
Intervention Description
Change the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.
Intervention Type
Drug
Intervention Name(s)
Undesirable TEG
Other Intervention Name(s)
blood sampling
Intervention Description
Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.
Primary Outcome Measure Information:
Title
Efficient Aspirin
Description
The value of inhibition rate of Aspirin > 50%
Time Frame
one year
Secondary Outcome Measure Information:
Title
Efficient Clopidogrel
Description
The value of adenosine diphosphate> 30%
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Platelet aggregability
Description
The value of maximum extent of thrombosis around 31-47 mm
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 14 years of age or older no gender aspirin or clopidogrel for ischemic cerebrovascular disease Primary or secondary prevention of ischemic stroke patients The researcher (or principal) signs the informed consent form Exclusion Criteria: Significant head trauma or stroke in the last 3 months 3 months to accept intracranial, spinal surgery or other parts of large surgery In the last week there is an incurable part of the artery puncture Acute bleeding constitution, including platelet count <100 × 109 / L or other conditions within the last 48h heparin treatment, APTT higher than the upper limit of normal range Oral anticoagulant: INR> 1.7 or PT> 15s The presence of intracranial tumors, aneurysms or arteriovenous malformations Patients with any of the following cardioembolic-related illnesses are identified: rheumatic mitral or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, Open foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular disease not suitable for enrollment; (as determined by the investigator) Severe liver and kidney dysfunction Life expectancy is less than 1 year Pregnant or lactating women Participating in other clinical studies, or have participated in other clinical studies within the 3 months before enrolling, or have already participated in this research Allergic or intolerant to aspirin or clopidogrel There are stomach lesions, such as gastritis, gastric ulcer and so on Do not want to follow-up or poor treatment compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moli Wang, 1
Phone
13801234991
Email
yifanhahahah@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Zhang, 2
Phone
13911256080
Email
zhangqian_zq@630.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Zhang, 1
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Director
Facility Information:
Facility Name
XuanWu hospital
City
Beijing
State/Province
Xicheng
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qian Zhang
Phone
13911256080
Email
zhangqian_zq630@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

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