ORETCR: Optimal Regimen in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance

Sponsor
Zhongrong Miao (Other)
Overall Status
Unknown status
CT.gov ID
NCT01925872
Collaborator
(none)
2,000
24

Study Details

Study Description

Brief Summary

  1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.

  2. Genetic polymorphisms are the most important factors to clopidogrel resistance.

  3. The purpose of this study is to find the genes which are the related to clopidogrel resistance.

  4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another drug maybe used to avoid the undesired efficacy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance
    Study Start Date :
    May 1, 2013
    Anticipated Primary Completion Date :
    May 1, 2015
    Anticipated Study Completion Date :
    May 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. genotype, platelet aggregation rate, cerebrovascular events [2 years]

      Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.

    Secondary Outcome Measures

    1. Active metabolite concentration [2 years]

      Active metabolite concentration depend on the genetic polymorphism.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database.

    • 90 days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis

    • stenosis ≥ 50% (MRI or CT angiography).

    • Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research.

    Exclusion Criteria:
    • diffuse intracranial arterial stenosis.

    • cranial magnetic resonance imaging shows lesions as the branch artery blockage caused.

    • non-atherosclerotic lesions.

    • occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage.

    • potential cardiac thrombus source.

    • has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation.

    • ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50%;

    • known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications;

    • hemoglobin less than 10g/dL, platelet count <100000/dL;

    • responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3);

    • international normalized ratio> 1.5

    • there are factors that can not be corrected by bleeding;

    • life expectancy <1 year;

    • pregnant or lactating women;

    • indications Commission determines that the patient is not suitable for the study treatment.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zhongrong Miao

    Investigators

    • Study Director: Ning Ma, Doctor, Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongrong Miao, principal investigator, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT01925872
    Other Study ID Numbers:
    • BTH-GENE-CR
    First Posted:
    Aug 20, 2013
    Last Update Posted:
    Jan 28, 2015
    Last Verified:
    Aug 1, 2013
    Keywords provided by Zhongrong Miao, principal investigator, Beijing Tiantan Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2015