Clinical trial NCT01925872: Optimal Regimen in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance
Official title: The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Cerebrovascular Disease
Keywords: ischemic cerebrovascular disease
Percutaneous transluminal angioplasty and stenting
Clopidogrel resistance
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: genotype, platelet aggregation rate, cerebrovascular events
timeFrame: 2 years
Secondary outcomes:
measure: Active metabolite concentration
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ning Ma, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.