2024-515924-35-00招募中4 期
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG - PACeS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 16
- 主要终点
- Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE))
研究概览
简要总结
The primary objective is the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset POAF after isolated CABG surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
- •POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG
排除标准
- •Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
- •Concomitant carotid artery endarterectomy during CABG
- •Concomitant aortic root replacement during CABG
- •Concomitant surgery for AF during CABG
- •Liver cirrhosis or Child-Pugh Class C chronic liver disease
- •Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial
- •Pregnancy at the time of randomization
- •Unable or unwilling to provide informed consent
- •Unable or unwilling to comply wit the study treatment and followup
- •Existence of underlying disease that limits life expectancy to less than one year
- •Women of childbearing potential (within two years after the last spontaneous menstruation) without effective contraceptive measures (Implanon, injections, oral contraceptives, intrauterine devices, vasectomized partner) during study participation. (Participants using hormone-based preparations must be informed about possible interactions with the study medication)
- •Any pre-existing clinical indication for long-term OAC
- •Participation in other interventional studies
- •Patients under legal supervision or guardianship
- •Any absolute contraindication to OAC
- •Planned use of post-operative dual antiplatelet therapy (DAPT)
- •Cardiogenic shock
- •Major perioperative complication occurring between CABG and randomization
- •Concomitant mitral valve annuloplasty during CABG
- •Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)
- •Concomitant mitral valve annuloplasty during CABG
结局指标
主要结局
Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE))
Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE))
Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5
Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5
次要结局
- Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism
- Net clinical benefit (NCB)
- Incidence of the primary effectiveness and safety endpoints at 180 days after randomization
- Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization
- Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization
- Incidence of BARC 2 bleeding at 90 and 180 days after randomization
- Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization
- Length of stay of index hospitalization
- Number and reasons for readmissions at 90 and 180 days after rendomization
- Hospital resource utilization at 180 days after surgey
- Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization
研究者
Anne Christine Gelijns
Scientific
Icahn School Of Medicine At Mount Sinai
研究点 (16)
Loading locations...
相似试验
进行中（未招募）
1 期
Preventing formation of blood clots due to atrial fibrillation, a cardiac arrhythmia that first occurred after coronary bypass surgery, with the help of anticoagulant medications.ew-Onset Post-Operative Atrial Fibrillation afterCABGMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersEUCTR2021-005022-18-DEIcahn School of Medicine at Mount Sinai3,200
招募中
1 期
Preventing formation of blood clots due to atrial fibrillation, a cardiac arrhythmia that first occurred after coronary bypass surgery, with the help of anticoagulant medications.CTIS2024-515924-35-00Icahn School Of Medicine At Mount Sinai3,200
招募中
3 期
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABGBleedingStrokeAtrial FibrillationNCT04045665Icahn School of Medicine at Mount Sinai3,200
招募中
2 期
Platelet inhibition versus direct oral anticoagulation in patients undergoing percutaneous closure of patent foramen ovale or atrial septal defect2024-517115-70-00Sint Antonius Ziekenhuis Stichting52
尚未招募
3 期
Early Anti-Coagulation therapy in new onset atrial fibrillation after coronary artery bypass graft operation; Warfarin vs Rivaroxaban for stroke preventioPost Operative Atrial Fibrillation.I48.0Paroxysmal atrial fibrillationIRCT20200304046696N1Tehran University of Medical Sciences1,590