Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03471169
• Collaborator: Chinese PLA General Hospital (Other), Peking University People's Hospital (Other)
• Enrollment: 3,500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 174.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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 Names: 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 Names: blood sampling

Outcome Measures

Primary Outcome Measures

1. Efficient Aspirin [one year]

   The value of inhibition rate of Aspirin > 50%

Secondary Outcome Measures

1. Efficient Clopidogrel [one year]

   The value of adenosine diphosphate> 30%

Other Outcome Measures

1. Platelet aggregability [one year]

   The value of maximum extent of thrombosis around 31-47 mm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	XuanWu hospital	Beijing	Xicheng	China	100053

Sponsors and Collaborators

• Xuanwu Hospital, Beijing
• Chinese PLA General Hospital
• Peking University People's Hospital

Investigators

• Study Director: Qian Zhang, 1, Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT03471169
• Other Study ID Numbers: jinqiaowml
• First Posted: Mar 20, 2018
• Last Update Posted: Mar 20, 2018
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Cerebrovascular Disorders

Study Results

No Results Posted as of Mar 20, 2018