- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00235248
Aortic Arch Related Cerebral Hazard Trial (ARCH) (ARCH)
Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques ≥ 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery
The ARCH is a controlled trial with a sequential design and with a prospective, randomized, open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy and tolerance (net benefit) of two antithrombotic strategies in patients with atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral embolic event.
Hypothesis:
The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.
연구 개요
상세 설명
Patients with Transient Ischemic attack or brain infarction of unknown cause (no ipsilateral internal carotid artery origin stenosis greater than 70%, no ipsilateral severe intracranial stenosis of an artery supplying the infarcted area, no definite cardiac source of embolism) in the preceding 6 months and atherosclerotic plaques.
≥ 4 mm in the aortic arch, or patients with a peripheral event (e.g. renal infarct) in the preceding 6 months and plaque ≥ 4 mm in the thoracic aorta above the origin of the embolized artery.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients of both sexes aged ≥ 18 years with the following 4 inclusion criteria:
One of the 3 following ischemic events in the preceding 6 months:
- Transient ischemic attack (TIA)
Non-disabling brain infarcts:
- Inclusion within 6 months after onset
- Duration of symptoms and signs greater than 24 hours
- Neurological signs at the time of randomization with a Rankin Scale grade 3 or less
- With normal computed tomography (CT) scan or CT scan showing a brain infarct (even hemorrhagic infarct)
- Peripheral embolism
- Atherosclerotic plaque in the thoracic aorta is defined as wall thickness ≥ 4 mm where the protruding material is the largest, measured at transesophageal echocardiography with multiplane transducer or a plaque less than 4 mm but with mobile component.
- Informed consent signed
- Life expectancy > 3 years
Exclusion Criteria:
Other causes of embolism:
- Cardiac: endocarditis, atrial fibrillation, intra-cardiac thrombus, valvular prosthesis, rheumatic valvulopathy, left ventricular aneurysm, or ejection fraction less than 25%
- Atherosclerotic stenosis ipsilateral to the embolic territory: internal carotid artery stenosis greater than 70%, or severe (judgment of the investigator) intracranial stenosis, or scheduled carotid endarterectomy (in that case inclusion is possible 30 days after the procedure)
- Uncommon causes: dissection, vasculitis, procoagulant state, or sickle cell disease
Other exclusion criteria:
- Intercurrent illness with life expectancy less than 36 months
- Pregnancy and non-menopausal women
- Unwillingness to participate
- Poor medication compliance expected
- Toxicomania
- Absolute indication for anticoagulant therapy (e.g. atrial fibrillation, intracardiac thrombus, prosthetic valve)
- Scheduled for carotid endarterectomy (randomization is possible 30 days after endarterectomy)
- CT scan with an intracranial lesion other than brain infarction (space occupying mass, intracranial hemorrhage)
- Transesophageal echocardiography (TEE) with plaque ≥ 4 mm in thickness distal to the supposed embolized artery (judgement of the investigator).
- Contraindication to clopidogrel, aspirin, and oral anticoagulants
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Clopidogrel-aspirin
|
Clopidogrel-aspirin
|
활성 비교기: Warfarin
|
와파린
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
기간: every 4 months
|
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
|
every 4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Recurrent brain infarction
기간: during the trial
|
Recurrent brain infarction
|
during the trial
|
brain infarction and transient ischemic attack (TIA)
기간: during the studing
|
brain infarction and transient ischemic attack (TIA)
|
during the studing
|
new vascular events and revascularization procedure
기간: during the trial
|
new vascular events and revascularization procedure
|
during the trial
|
vascular death
기간: during the trial
|
vascular death
|
during the trial
|
death from all causes
기간: during the trial
|
death from all causes
|
during the trial
|
combination of primary end-point and TIA
기간: during the trial
|
combination of primary end-point and TIA
|
during the trial
|
revascularization procedures
기간: during the trial
|
revascularization procedures
|
during the trial
|
urgent rehospitalization for ischemic
기간: during the trial
|
urgent rehospitalization for ischemic
|
during the trial
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pierre Amarenco, Pr, MD, PhD, Assistance Publique - Hôpitaux de Paris
간행물 및 유용한 링크
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
키워드
추가 관련 MeSH 약관
- 국소 빈혈
- 병리학적 과정
- 회저
- 심혈관 질환
- 혈관 질환
- 뇌혈관 장애
- 뇌 질환
- 중추신경계 질환
- 신경계 질환
- 색전증 및 혈전증
- 뇌허혈
- 뇌졸중
- 경색
- 색전증
- 허혈 발작, 일시적
- 뇌경색
- 약물의 생리적 효과
- 신경 전달 물질
- 약리작용의 분자기전
- 말초 신경계 작용제
- 효소 억제제
- 진통제
- 감각 시스템 에이전트
- 항염증제, 비스테로이드성
- 진통제, 비마약성
- 항염증제
- 항류마티스제
- 섬유소용해제
- 피브린 조절제
- 혈소판 응집 억제제
- 사이클로옥시게나제 억제제
- 해열제
- 퓨린성 P2Y 수용체 길항제
- 퓨린성 P2 수용체 길항제
- 퓨린성 길항제
- 퓨린 작용제
- 항응고제
- 아스피린
- 클로피도그렐
- 와파린
기타 연구 ID 번호
- P991205
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. .
와파린에 대한 임상 시험
-
University of EdinburghChief Scientist Office of the Scottish Government모병