Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (TAP-CABG)
Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)
연구 개요
상세 설명
Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.
Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.
CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.
The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다
- Vancouver General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
- Females of child-bearing age must have a negative pregnancy test at enrollment
Exclusion Criteria:
- Patients undergoing combined valve or aortic surgeries
- Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
- Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
- Patients with active bleeding or history of bleeding diathesis
- Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
- Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
- Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
- Patients with end-stage renal failure requiring dialysis
- For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Placebo
Placebo twice daily.
Study drug will be started within 48 hours of CABG.
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Placebo 1 pill BID for 90 days
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활성 비교기: ticagrelor 90 mg
Taken twice daily.
Study drug will be started within 48 hours of CABG.
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ticagrelor 90 mg BID for 90 days
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Composite of all-cause mortality, MI, stroke, or repeat revascularization
기간: within one year following CABG
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within one year following CABG
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improving graft patency
기간: 3 months post-CABG
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The secondary study objective is to evaluate if the combination of ticagrelor and aspirin administered after CABG will improve graft patency at 3 months, compared with aspirin alone.
This will be monitored and assessing in the CT angiography substudy.
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3 months post-CABG
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jackie Saw, BSc, MD, FRCPC, University of British Columbia
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- H10-01452
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