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

NCT01925872 | Unknown

• 1 other identifier: BTH-GENE-CR
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.
2. 2.Genetic polymorphisms are the most important factors to clopidogrel resistance.
3. 3.The purpose of this study is to find the genes which are the related to clopidogrel resistance.
4. 4.Through gene sequencing, we can filter patient of clopidogrel resistance, so another drug maybe used to avoid the undesired efficacy.

Conditions

Ischemic Cerebrovascular Disease

Keywords

ischemic cerebrovascular disease; Percutaneous transluminal angioplasty and stenting; Clopidogrel resistance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Active metabolite concentration

  2 years

Eligibility Criteria

• Age: 25 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongrong Miao: lead

Related Publications (2)

• Li XG, Ma N, Sun SS, Xu Z, Li W, Wang YJ, Yang X, Miao ZR, Zhao ZG. Association of genetic variant and platelet function in patients undergoing neuroendovascular stenting. Postgrad Med J. 2017 Sep;93(1103):555-559. doi: 10.1136/postgradmedj-2016-134745. Epub 2017 Mar 9.

  PMID: 28280103 DERIVED

• Wang B, Li XQ, Ma N, Mo D, Gao F, Sun X, Xu X, Liu L, Song L, Li XG, Zhao Z, Zhao X, Miao ZR. Association of thrombelastographic parameters with post-stenting ischemic events. J Neurointerv Surg. 2017 Feb;9(2):192-195. doi: 10.1136/neurintsurg-2015-011687. Epub 2015 Jun 3.

  PMID: 26041100 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood were retained to extract DNA for genetic sequencing.

Study Officials

• Ning Ma, Doctor

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 20, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 28, 2015

Record last verified: 2013-08