심방세동 환자에서 Rivaroxaban과 Apixaban의 출혈 위험 비교 (COBRRA-AF)
Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity and mortality. Having a stroke can affect a patient's ability to speak, eat, walk, work, care for themselves, and interact with others. Not only can it ruin one's life, but it can also be fatal. A stroke occurs when blood flow to the brain is blocked by a clot, depriving brain cells of oxygen. In people with atrial fibrillation, blood flow is sluggish in the top chambers of the heart, and blood clots can form there. When a piece of a clot breaks off, it can travel to the brain and cause a stroke. That's where blood thinners come in. Blood thinners, or anticoagulants, decrease the chances of blood clots forming in the heart, reducing the risk of stroke. Studies show that blood thinners are highly effective at reducing the risk of stroke by up to 95%.
The conventional blood thinner is warfarin, taken by mouth. Warfarin requires regular blood tests to make sure a patient getting the correct dose. The patient also may have to avoid certain foods since the medication can interact with them. Newer blood thinners, known as direct-oral anticoagulants (DOACs) are available, which do not require regular blood tests and do not interact with foods. Two of the new blood thinners are called rivaroxaban and apixaban. Like warfarin, they can be taken by mouth, and studies have shown them to be as effective as warfarin.
Both rivaroxaban and apixaban have been approved for stroke prevention in AF by Health Canada. However, there have been no direct head-to-head comparisons of these two anticoagulants, meaning comparative safety data is not available. Increasing use of DOACs for stroke prevention in AF and patient values around bleeding highlight the need for a comparison trial to ensure patients receive the anticoagulant with the greatest balance of benefit to potential harm.
The trial is to assess bleeding rates and superiority of using apixaban versus rivaroxaban in patients with non-valvular atrial fibrillation.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Atrial Fibrillation (AF) affects 200,000 Canadians and increases risk of stroke, morbidity and mortality. Oral anticoagulants such as Vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are highly effective at reducing the risk of stroke by up to 95%. Randomized controlled trials (RCTs) have compared apixaban and rivaroxaban (both DOACs) to VKAs for stroke prevention in AF, and are approved for this use by Health Canada. However, there have been no direct head-to-head comparisons of these two anticoagulants, meaning comparative safety data is not available. Increasing use of DOACs for stroke prevention in AF, patient values around bleeding, and litigation highlight the need for a comparison trial to ensure patients receive the anticoagulant with the greatest balance of benefit to potential harm.
The objective of this RCT is to compare the safety of the first 12 months of apixaban twice daily to rivaroxaban once daily in patients with non-valvular AF (NVAF). Patients will be monitored for the primary outcome of clinically relevant bleeding (CRB; a composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events during follow-up. This trial will directly inform clinical practice and the choice of first-line therapy.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Lana Castellucci, MD
- 전화번호: 75481 613-737-8899
- 이메일: lcastellucci@toh.ca
연구 연락처 백업
- 이름: Erin Thomas
- 이메일: erithomas@toh.ca
연구 장소
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British Columbia
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Victoria, British Columbia, 캐나다, V8Z 0B9
- 빼는
- Victoria Cardiac Arrhythmia Trials
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Nova Scotia
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Halifax, Nova Scotia, 캐나다
- 모병
- QEII Health Science Centre
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수석 연구원:
- Ratika Parkash, MD
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연락하다:
- Katie Kawulka
- 이메일: katie.kawulka@nshealth.ca
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Ontario
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Kingston, Ontario, 캐나다
- 모병
- Kingston General Hospital
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수석 연구원:
- Kerstin de Wit, MD
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연락하다:
- Huba Rana
- 이메일: huba.rana1@kingstonhsc.ca
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연락하다:
- Tanya Gilpin
- 이메일: tanya.gilpin@kingstonhsc.ca
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Ottawa, Ontario, 캐나다, K1H 8L6
- 모병
- The Ottawa Hospital - General Campus
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수석 연구원:
- Lana Castellucci, MD
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연락하다:
- Daniel Warner
- 전화번호: 79590 613-737-8899
- 이메일: dawarner@ohri.ca
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연락하다:
- Erin Thomas
- 이메일: erithomas@toh.ca
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Ottawa, Ontario, 캐나다
- 모병
- University Ottawa Heart Institute
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연락하다:
- Hannah Feagan
- 전화번호: 14125 613-696-7000
- 이메일: hfeagan@ottawaheart.ca
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연락하다:
- Colleen Ratelle
- 이메일: cratelle@ottawaheart.ca
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수석 연구원:
- Daniel Ramirez, MD
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Quebec
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Gatineau, Quebec, 캐나다, J8T 4J3
- 모병
- CISSS de l'Outaouais
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연락하다:
- Celine Roy
- 이메일: celine.roy@ssss.gouv.qc.ca
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연락하다:
- Gladice Salem
- 이메일: gladice_salem@ssss.gouv.qc.ca
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수석 연구원:
- Dr. Jean-Michel Guay, MD
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Laval, Quebec, 캐나다
- 아직 모집하지 않음
- CHU de Quebec - Université Laval
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연락하다:
- Eric Mercier, MD
- 이메일: eric.mercier@fmed.ulaval.ca
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수석 연구원:
- Dr. Eric Mercier, MD
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Montreal, Quebec, 캐나다, H3L 1K5
- 모병
- Ciusss Nim
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연락하다:
- Dr. Alexis Cournoyer, MD
- 이메일: alexiscournoyermus@gmail.com
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연락하다:
- Chantal Lanthier
- 이메일: chantal.lanthier.cnmtl@ssss.gouv.qc.ca
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수석 연구원:
- Dr. Alexis Cournoyer, MD
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ≥ 18 years old
- Confirmed new diagnosis of AF on ECG with an indication to start anticoagulation according to Canadian Cardiovascular Society guidelines
Exclusion Criteria:
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Creatinine clearance =<15 ml/min calculated using the Cockcroft-Gault formula
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Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to:
- active bleeding
- history of mechanical valve
- other indication for anticoagulation (e.g. mechanical valves, venous thrombosis)
- dual antiplatelet agent use
- known liver disease with coagulopathy
- use of contraindicated medications (strong inducers/inhibitors of CYP 3A4/5, P-glycoprotein)
- pregnancy or breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Apixaban group
5 mg PO, twice daily for 12 months of treatment. A dose reduction* to 2.5 mg twice daily will apply if patients meet 2 of 3 following criteria: age > 80 years; weight < 60 kg; creatinine >133 micromol/L. *Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually |
Refer to Apixaban group
다른 이름들:
|
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활성 비교기: Rivaroxaban Group
20 mg PO, once daily for 12 months of treatment. A dose reduction* to 15 mg daily will apply to patients with creatinine clearance <50 ml/min. *Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually |
Refer to Rivaroxaban group
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The rate of adjudicated clinically relevant bleeding (CRB) events
기간: For the duration of the study: 12 months
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CRB events are defined as the composite of major bleeding (MB) events and clinically relevant non-major bleeding (CRNMB) events |
For the duration of the study: 12 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adjudicated Major Bleeding events
기간: For the duration of the study: 12 months
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Major Bleeding includes clinically overt bleeding and is associated with:
|
For the duration of the study: 12 months
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Adjudicated Clinically Relevant Non-Major Bleeding events
기간: For the duration of the study: 12 months
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Clinically relevant non-major bleeding will be defined as: • Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
|
For the duration of the study: 12 months
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Adjudicated stroke/TIA events
기간: For the duration of the study: 12 months
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Stroke is defined as non-traumatic focal neurologic deficit lasting ≥ 24 hours and confirmed on cerebral imaging (computed tomography or magnetic resonance imaging). Transient ischemic attack (TIA) is defined as a temporary loss of blood flow to a part of the brain with focal neurologic deficit lasting < 24 hours without imaging evidence of acute infarction. Strokes are to be classified as ischemic, hemorrhagic stroke, or uncertain. Hemorrhagic strokes are considered and will be reported as both bleeding events as well as stroke endpoints. The location of the bleeding can be determined from the diagnostic imaging reports. |
For the duration of the study: 12 months
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All-cause mortality
기간: For the duration of the study: 12 months
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Using a binary outcome of an event or no event (Individual rates of death, all causes). |
For the duration of the study: 12 months
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Medication adherence
기간: For the duration of the study: 12 months
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Reported as the number of patients self-reporting "all assigned medications were taken" "missing at least one dose of study medication", or "not able to take all of the study medications" out of the total number of medication compliance assessments done respectively |
For the duration of the study: 12 months
|
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Incremental cost-effectiveness ratio
기간: For the duration of the study: 12 months
|
We will model the prognosis of a cohort of patients receiving rivaroxaban versus apixaban. The results will be presented as incremental cost per QALY gained, incremental costs per one clinically relevant bleeding cases prevented, and incremental cost per one life year saved. |
For the duration of the study: 12 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Lana Castellucci, MD, FRCPC, Ottawa Hospital Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- COBRRA-AF
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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