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Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

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ClinicalTrials.gov Identifier: NCT03471169
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Chinese PLA General Hospital
Peking University People's Hospital
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief Summary:
To investigate the therapeutic effect of individualized treatment of antiplatelet in secondary prevention of ischemic stroke.

Condition or disease Intervention/treatment Phase
Cerebrovascular Disease Drug: Desirable TEG Drug: Undesirable TEG Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Arm Intervention/treatment
Experimental: Desirable TEG
Patients receiving antiplatelet medication and desirable thrombelastogram(TEG) test results.
Drug: Desirable TEG

Change the type and dose of antithrombotic therapy and obtain desirable TEG results.

Antithrombotic drugs inclued Bayaspirin®,Plavix ® and Cilostazol.

Other Name: blood sampling

Sham Comparator: Undesirable TEG
Patients receiving antiplatelet medication and undesirable thrombelastogram(TEG) test results.
Drug: Undesirable TEG
Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®,Plavix ® and Cilostazol.
Other Name: blood sampling




Primary Outcome Measures :
  1. Efficient Aspirin [ Time Frame: one year ]
    The value of inhibition rate of Aspirin > 50%


Secondary Outcome Measures :
  1. Efficient Clopidogrel [ Time Frame: one year ]
    The value of adenosine diphosphate> 30%


Other Outcome Measures:
  1. Platelet aggregability [ Time Frame: one year ]
    The value of maximum extent of thrombosis around 31-47 mm



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471169


Contacts
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Contact: Moli Wang, 1 13801234991 yifanhahahah@163.com
Contact: Qian Zhang, 2 13911256080 zhangqian_zq@630.sina.com

Locations
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China, Xicheng
XuanWu hospital Recruiting
Beijing, Xicheng, China, 100053
Contact: qian Zhang    13911256080    zhangqian_zq630@sina.com   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Chinese PLA General Hospital
Peking University People's Hospital
Investigators
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Study Director: Qian Zhang, 1 Xuanwu Hospital, Beijing

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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03471169     History of Changes
Other Study ID Numbers: jinqiaowml
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Xuanwu Hospital, Beijing:
antithrombotic therapy

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases