Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

Cerebrovascular Disease Clinical Trial

Official title:

Studies on the Individualized Prevention of Cerebrovascular Disease Using Study on Antithrombotic Therapy in Beijing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03471169
• Other study ID #: jinqiaowml
• Status: Recruiting
• Phase: Phase 1
• First received: December 5, 2017
• Last updated: March 13, 2018
• Start date: April 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: Xuanwu Hospital, Beijing
• Contact: Moli Wang, 1
• Phone: 13801234991
• Email: yifanhahahah[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Drug:
• Desirable TEG
Change the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®,Plavix ® and Cilostazol.
• Undesirable TEG
Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®,Plavix ® and Cilostazol.

Locations

Country	Name	City	State
China	XuanWu hospital	Beijing	Xicheng

Sponsors (3)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Chinese PLA General Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Platelet aggregability	The value of maximum extent of thrombosis around 31-47 mm	one year
Primary	Efficient Aspirin	The value of inhibition rate of Aspirin > 50%	one year
Secondary	Efficient Clopidogrel	The value of adenosine diphosphate> 30%	one year