Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,010
- 试验地点
- 88
- 主要终点
- Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months
研究概览
简要总结
Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.
The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.
In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.
In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").
详细描述
Background:
The optimal antithrombotic treatment following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) requiring long-term oral anticoagulation remains a matter of debate. In particular, the appropriate intensity and duration of antithrombotic strategies to prevent ischemic events, while mitigating the risk of bleeding complications in this high bleeding risk population during the early peri-procedural period (within 30 days) and thereafter (from 30 days to 1 year) following drug-eluting stent implantation remains unclear.
Aim:
The investigators aim to assess the safety and efficacy of a P2Y12 inhibitor monotherapy regimen for 1 month followed by DOAC monotherapy long-term versus current standard of care consisting of triple antithrombotic therapy for up to one month (aspirin, P2Y12 inhibitor and DOAC) followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and DOAC monotherapy thereafter, in AF patients undergoing PCI indicated for treatment with a DOAC after sirolimus-eluting Supraflex Cruz stent implantation and followed for a period of 12 months.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months
- •Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.
- •Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.
- •Written informed consent
排除标准
- •Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)
- •Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion
- •AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure
- •Prior mechanical valvular prosthesis implantation
- •Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation
- •Stroke within 1 month prior to randomization
- •Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
- •Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥120 mmHg
- •Severe renal impairment with estimated creatinine clearance (CrCL) <15 mL/min or on dialysis
- •Moderate or severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
- •Any hypersensitivity or contraindications for direct oral anticoagulation or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor
- •Any of the following abnormal local laboratory results prior to randomization: platelet count <50 x109/L or hemoglobin <8 g/dL
- •Known pregnancy or breast-feeding patients
- •Life expectancy <1 year due to other severe non-cardiac disease
- •Planned surgery including coronary artery bypass grafting within the next 6 months
结局指标
主要结局
Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months
Major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke, or non-CNS systemic embolism between randomization and up to 12 months
Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months
Major or clinically relevant non-major bleeding (MCB) defined according to the International Society of Thrombosis and Hemostasis (ISTH) criteria between randomization and up to 12 months
次要结局
- Transient ischemic attack
- Hemorrhagic stroke
- The individual components of each primary endpoints
- The composite of death from cardiovascular causes, myocardial infarction, or stroke
- The composite of death from cardiovascular causes, myocardial infarction, stroke or non-CNS systemic embolism
- Death from cardiovascular or non-cardiovascular causes
- The composite of stroke and non-CNS systemic embolism
- Any stroke (including ischemic, hemorragic, and unknown types)
- Ischemic stroke
- The composite of definite or probable stent thrombosis
- Definite stent thrombosis
- Hospitalization
- The composite of death or hospitalization
- Any target lesion revascularization
- Any target vessel revascularization
- Any revascularization
- All bleeding events, also adjudicated according to BARC, TIMI or GUSTO scales
- Transfusion rates both in patients with and/or without clinically detected overt bleeding
研究者
Phidealive srl
Scientific
Insel Gruppe AG