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

January 27, 2015 updated by: Zhongrong Miao

The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance

  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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database; 90 days had a stroke or TIA 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genotype, platelet aggregation rate, cerebrovascular events
Time Frame: 2 years
Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active metabolite concentration
Time Frame: 2 years
Active metabolite concentration depend on the genetic polymorphism.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongrong Miao

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 17, 2013

First Posted (ESTIMATE)

August 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTH-GENE-CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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