Individualized Antithrombotic Therapy for Patients With Ischemic Cerebrovascular Disease

NCT03471169 | Unknown Phase 1

• 1 other identifier: jinqiaowml
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebrovascular Disease

Keywords

antithrombotic therapy

Outcome Measures

Primary Outcomes (1)

• Efficient Aspirin

  The value of inhibition rate of Aspirin \> 50%

  one year

Secondary Outcomes (1)

• Efficient Clopidogrel

  one year

Other Outcomes (1)

• Platelet aggregability

  one year

Study Arms (2)

Desirable TEG

EXPERIMENTAL

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

Drug: Desirable TEG

Undesirable TEG

SHAM COMPARATOR

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

Drug: Undesirable TEG

Interventions

Desirable TEG DRUG

Change the type and dose of antithrombotic therapy and obtain desirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Also known as: blood sampling

Desirable TEG

Undesirable TEG DRUG

Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.

Also known as: blood sampling

Undesirable TEG

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant head trauma or stroke in the last 3 months
• 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

Sponsors & Collaborators

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

Study Sites (1)

XuanWu hospital

Beijing, Xicheng, 100053, China

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Qian Zhang, 1

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Moli Wang, 1

CONTACT

13801234991; yifanhahahah@163.com

Qian Zhang, 2

CONTACT

13911256080; zhangqian_zq@630.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: March 20, 2018
• Study Start: April 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)