- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01894789
Ticagrelor vs Clopidogrel Effect on MFR in CAD Population (PATH)
ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.
This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.
This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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-
Ontario
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Ottawa, Ontario, 캐나다, K1Y 4W7
- University of Ottawa Heart Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years old
- Stable coronary artery disease on stable medical treatment.
- BMI equal to or less than 30 kg/m2
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant arrhythmias on baseline 12-lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.
Exclusion Criteria:
- Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
- Oral anticoagulation therapy.
- History of intracranial bleeding.
- Recent or active pathological bleeding, such as peptic ulcer.
- Moderate or severe hepatic impairment.
- History or risk of bradycardia.
- Known second- or third-degree AV block without pacemaker
- Dyspnea (NYHA III/IV), wheezing asthma or COPD.
- Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
- Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
- Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
- Any scheduled surgery during the trial period, including dental.
- Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
- Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
- Known hypersensitivity to the investigational drug or any of its components.
- Known hypersensitivity to adenosine.
- Lactose intolerance
- Breastfeeding or pregnancy.
- Claustrophobia or inability to lie still in a supine position
- Unwillingness to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: stable CAD management
Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day
|
Blinded administration of ticagrelor for 10 days
다른 이름들:
Blinded administration of clopidogrel and placebo for 10 days
|
|
활성 비교기: CAD comparison group
Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day.
|
Blinded administration of ticagrelor for 10 days
다른 이름들:
Blinded administration of clopidogrel and placebo for 10 days
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET
기간: q 2 weeks blood flow measurements
|
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effect will not be known until the study has completed and the treatment unblinded. |
q 2 weeks blood flow measurements
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects
기간: q 2 weeks blood flow measurements
|
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded. |
q 2 weeks blood flow measurements
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Terrence Ruddy, MD, Ottawa Heart Institute Research Corporation
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20130105-01H
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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