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

Ischemic Cerebrovascular Disease Clinical Trial

— ORETCR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01925872
• Other study ID #: BTH-GENE-CR
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 15, 2013
• Last updated: January 27, 2015
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2013
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 95 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Ischemia
• Ischemic Cerebrovascular Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongrong Miao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genotype, platelet aggregation rate, cerebrovascular events	Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.	2 years	Yes
Secondary	Active metabolite concentration	Active metabolite concentration depend on the genetic polymorphism.	2 years	Yes