- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01283282
Investigation of the Athero-Protective Effects of Clopidogrel (APECS)
2015년 4월 15일 업데이트: Arshed A. Quyyumi, Emory University
Phase 4 Study of Clopidogrel in Patients With Stable Coronary Artery Disease to Determine Effects on Vascular Function, Biomarkers and Endothelial Progrenitor Cells
The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels.
The investigators will give half of the patients clopidogrel and the other half a sugar pill, placebo, and check the levels of these markers and helpful cells in each group.
At the same time the investigators will check how well these patient's blood vessels work using ultrasound imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's blood vessels are.
After 6 weeks of drug therapy, the patients will switch to the other drug and these same tests will be performed after an additional 6 weeks of therapy.
The drug taken by the patient will not be known to the patient or the researchers.
The patients will continue on their prescribed medical therapy during the duration of the 12 week study.
연구 개요
상세 설명
Blockages in the blood vessels of the heart are caused by atherosclerosis.
Atherosclerosis is the main cause for chest pain and heart attacks.
Gradual narrowing of the vessels of the heart caused by blockages causes chronic symptoms, such as chest pain.
Those with these findings often have a cardiac catheterization to detect these blockages.
Additionally these patients may have an angioplasty or stent placed to help relieve these symptoms.
With this angioplasty/stent procedure, patients are placed on the drug clopidogrel to help prevent clots from forming and narrowing of the blood vessels.
Clopidogrel is a blood thinner that prevents clots from forming similar to an aspirin, but is more powerful and effective.
Markers, or substances, have been identified that cause worsening of the blockages in the blood vessels of the heart.
Many of these substances have been shown to decrease with the use of clopidogrel.
This occurs separately from clopidogrel's ability to prevent clots.
Endothelial progenitor cells, or EPCs, come mostly from the bone marrow and is helpful in repairing damage to the lining of the blood vessels of the heart.
The EPCs help balance out the damage incurred in the blood vessels from those harmful markers.
Several other drugs commonly used in heart disease have recently been shown to improve EPCs function.
With this in mind, it is important to understand more of clopidogrel's function.
A decrease in markers that cause worsening of the blockages, and an increase in the number of cells that will help repair damaged blood vessels of the heart is important in avoiding future chest pain and heart attacks.
This may be how clopidogrel is currently protecting patients from developing new blockages.
The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels.
The investigators will give half of the patients clopidogrel and the other half a sugar pill, placebo, and check the levels of these markers and helpful cells in each group.
At the same time the investigators will check how well these patient's blood vessels work using ultrasound imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's blood vessels are.
After 6 weeks of drug therapy, the patients will switch to the other drug and these same tests will be performed after an additional 6 weeks of therapy.
The drug taken by the patient will not be known to the patient or the researchers.
The patients will continue on their prescribed medical therapy during the duration of the 12 week study.
연구 유형
중재적
등록 (실제)
48
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or females without child bearing potential aged 21-80 years
- Known coronary artery disease by angiogram or documented myocardial infarction.
- Able to provide written informed consent
Exclusion Criteria:
- Treated with clopidogrel or ticlodipine in the previous 3 months
- Age < 21 or >80 years
- Premenopausal females with potential for pregnancy
- Allergy to clopidogrel or aspirin
- Initiation or change in dose of any concomitant medical therapy within 2 months before the study
- Uncontrolled hypertension with BP>180 mmHg systolic and >120 mmHg diastolic
- Treated with coumadin therapy
- Intolerance or allergy to statins
- Acute infection in previous 4 weeks
- History of substance abuse
- Uninterpretable PAT test
- Current neoplasm
- Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X normal)
- Acute coronary syndrome, heart failure, CVA, coronary intervention within 3 months
- Known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.
- Inability to give informed consent
- Inability to return to Emory for follow-up
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Clopidogrel/Placebo
Subjects were randomized to clopidogrel 75 mg daily for 6 weeks.
Then immediately transitioned to a placebo daily for 6 weeks.
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Clopidogrel 75 mg PO qday for 6 weeks
다른 이름들:
Placebo PO qday for 6 weeks
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활성 비교기: Placebo/Clopidogrel
Subjects were randomized to a placebo daily for 6 weeks.
Then immediately transitioned to clopidogrel 75 mg daily for 6 weeks.
|
Clopidogrel 75 mg PO qday for 6 weeks
다른 이름들:
Placebo PO qday for 6 weeks
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Flow-mediated Dilation (FMD)
기간: Baseline, Week 12
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Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.
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Baseline, Week 12
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Nitroglycerin-mediated Vasodilation
기간: Baseline, Week 12
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Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually.
Brachial artery images were obtained via ultrasound after three minutes of NTG administration.
Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.
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Baseline, Week 12
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Endothelial Progenitor Cells (EPCs)
기간: Week 12
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The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+
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Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pulse Wave Velocity (PWV)
기간: Week 12
|
PWV was measured between the carotid and femoral arteries using the SphygmoCor device.
Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating.
Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.
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Week 12
|
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Oxidative Stress Markers
기간: Week 12
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Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.
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Week 12
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Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)
기간: Week 12
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High-sensitivity C-reactive protein (hsCRP) was measured.
The hsCRP levels were measured by Dade Behring nephelometry.
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Week 12
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Inflammatory Marker CD40 Ligand
기간: Week 12
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CD40 ligand levels were measured.
The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.
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Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Ziyad Ghazzal, MD, American University of Beirut, Emory University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 1월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2010년 12월 1일
연구 등록 날짜
최초 제출
2011년 1월 24일
QC 기준을 충족하는 최초 제출
2011년 1월 24일
처음 게시됨 (추정)
2011년 1월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 4월 15일
마지막으로 확인됨
2015년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00005145
- APECS (기타 식별자: Other)
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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