- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01955642
Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke (AAPIX)
Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke : Role of Platelet alpha2-adrenergic Receptors
Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second leading cause of dementia and the third leading cause of death in France.
Clopidogrel is one of the recommended first line in the secondary prevention of AIC non cardioembolic origin. However recurrences occur in approximately 9% of patients receiving clopidogrel. Some studies in patients with coronary artery disease have made the connection between these treatment failures and non-biological response to clopidogrel. This non-biological response is found for approximately 30% to 50% of patients. Several mechanisms may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed, clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of proteins involved in these two steps explain the low plasma concentration of active metabolites and thus the low efficacy of clopidogrel in some patients.
A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response to clopidogrel.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Saint-etienne, 프랑스, 42000
- Chu de Saint-Etienne
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Consent signed
- Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications
- normal standard biological tests
Exclusion Criteria:
- Need to continue aspirin therapy
- Patients with a recurrence of clopidogrel AIC
- Patient already tacking clopidogrel
- Drugs interfering with the adrenergic system alpha blockers, alpha 2 receptor agonists (alpha-methyldopa) and alpha2 receptor inhibitors (Mianserin, Mirtazapine, yohimbine)
- Contra indication of clopidogrel and / or any of its excipients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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AVC
Patients with non-cardioembolic AIC requiring initiation of treatment with clopidogrel as usual indications
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75 mg milligrams per days of PLAVIX
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
adrenergic component of the platelet response
기간: 5 days after taking clopidogrel
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adrenergic component of the platelet response is estimated by the difference between the maximum percentage of platelet aggregation by light transmission aggregometry (LTA) with the addition of ADP(adenosine diphosphate) + ADP versus selective agonist (epinephrine)
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5 days after taking clopidogrel
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
VASP-CMF
기간: After 5 days taking clopidogrel
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Platelet reactivity index (PRI) by VASP CMF (flow cytometry) method
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After 5 days taking clopidogrel
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ELISA VASP
기간: After 5 days taking clopidogrel
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Platelet reactivity index (PRI-ELISA) using ELISA VASP
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After 5 days taking clopidogrel
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active metabolite of clopidogrel
기간: After 5 days taking clopidogrel
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Rate of residual plasma active metabolite of clopidogrel (R-130964)
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After 5 days taking clopidogrel
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Genotyping of MDR-1 and P450 2C19
기간: After 5 days taking clopidogrel
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Genotyping of MDR-1 and P450 2C19
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After 5 days taking clopidogrel
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jerome VARVAT, MD, Chu de Saint-Etienne
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1208094
- 2013-000313-20 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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