EUCTR2016-002683-14-NL进行中（未招募）1 期
Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist-based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement. (EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI - ENTRUST AF-PCI).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,506
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting in adult male and female patients =18 years of age.
- •Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.
- •Successful PCI definition:
- •The success of a PCI procedure is defined by 2 interrelated components: angiographic findings, procedural / clinical outcomes as detailed below:
- •Angiographic Success
- •A minimum stenosis diameter of < 20% (as visually assessed by angiography - residual blockage or stenosis reduced to less than 20% of the artery’s diameter).
- •Sufficient enlargement of the lumen at the target site to improve coronary artery blood flow with final TIMI flow grade 3 (visually assessed by angiography), without occlusion of a significant side branch, flow-limiting dissection, distal embolization, or angiographic thrombus.
- •Procedural Success
- •No major in-hospital clinical complications(e.g. ongoing ISTH major or clinical relevant non-major procedural bleeding at the time of randomization, stroke, emergency CABG).
- •In summary, a clinically successful PCI requires both anatomic and procedural success along with relief of signs and/or symptoms of myocardial ischemia at the time of randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
排除标准
- •Bleeding risks or systemic conditions
- •1.Known bleeding diathesis, including but not limited to,
- •a.Uncontrolled active bleeding, encompassing both ISTH major and clinically relevant non-major bleeding, preceding randomization.
- •b.Lesion or condition, if considered to be a significant risk for major bleeding.
- •This may include but is not limited to: unresolved gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities.
- •Medication-related
- •2.INR > 2.5 (the subject can be reconsidered at a later time, but within 5 days of sheath removal).
- •3.Contraindication to edoxaban, VKA, ASA and/or P2Y12 antagonists;
- •4.Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Concomitant conditions and therapies
- •5.Critically ill or hemodynamically unstable subjects (at the time of randomization) including:
- •a.cardiogenic shock or acute decompensated heart failure, with the requirement for vasopressor agents or inotropic support or mechanical support to support circulation
- •b.respiratory failure requiring endotracheal intubation and mechanical ventilation.
- •6.Any prior mechanical valvular prosthesis;
- •7.Planned coronary or vascular intervention or major surgery within 12 months; Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure;
- •8.Moderate or severe mitral stenosis;
- •9.Ischemic stroke within 2 weeks prior to randomization;
- •10.Uncontrolled severe hypertension with a systolic blood pressure (BP) =180 mmHg and/or diastolic BP = 120 mmHg;
- •11.End stage renal disease (ESRD) (CrCL<15 mL/min) or on dialysis;
- •12.Known abnormal liver function prior to randomization (incl. hepatic disease or biochemical evidence of significant liver derangement known prior to randomization
- •Other exclusion criteria
- •13.Any of the following abnormal local laboratory results prior to randomization:
- •a.Platelet count < 50 x109/L
- •b.Hemoglobin < 8 mg/dL
- •14.Unable to provide written IC;
- •15.Female subjects of childbearing potential without using highly effective contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study). Females taking oral contraceptives should have been on therapy for at least three months.
- •Adequate contraceptives include: Combined (estrogen and progestogen containing) oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;
- •16.Pregnant or breast-feeding subjects;
- •17.Assessment that the subject is not likely to comply with the study procedures or have complete follow-up;
- •18.Participating in another clinical trial that potentially interferes with the current study;
- •19.Previous randomization in this study;
- •20.Active on prescription drug abuse and addiction; abuse of illicit substances (i.e. marijuana, cocaine, methamphetamine, her
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