NCT02832531撤回3 期
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Time from randomization to the first occurrence of Stroke or systemic embolism
研究概览
简要总结
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.
A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RVHD diagnosed by echocardiography at any time prior to enrollment
- •Increased risk of stroke by any of the following
- •CHA2DS2-VASc score ≥ 2 OR
- •Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
- •Left atrial spontaneous echo contrast OR
- •Left atrial thrombus
- •Heart Rhythm
- •AF or Flutter and unsuitable for VKA therapy. (AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram). OR
- •In the absence of AF or Flutter, patients would be eligible in the presence of any one of the following:
- •Left atrial enlargement ≥5.5 cm OR
- •Left atrial spontaneous echo contrast OR
- •Left atrial thrombus OR
- •Frequent ectopic atrial activity (>1000/24 hours) on Holter monitoring
排除标准
- •Refusal to give informed consent
- •Actively involved in any study that would compromise the protocol of INVICTUS Trial
- •Severe co-morbid condition with life expectancy < 1 year
- •Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
- •Likely to have valve replacement surgery within 6 months
- •Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.
- •Contraindication to the study medication of the trial
- •Allergy to rivaroxaban
- •Allergy to VKAs ( non-inferiority trial)
- •Allergy to aspirin ( superiority trial)
- •Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15 ml/min
- •Serious bleeding in the past six months or at high risk for bleeding
- •Moderate to severe hepatic impairment
- •Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
- •Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
- •Received an investigational drug in the past 30 days
- •Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
- •Women who are pregnant and/or breastfeeding
- •Women of child bearing age who do not use an effective form of birth control.
研究组 & 干预措施
Rivaroxaban (15 mg)
Experimental
Rivaroxaban 15 mg od (n ~ 1000)
干预措施: Rivaroxaban (15 mg) (Drug)
Aspirin (ASA)
Active Comparator
Aspirin 100 mg od (n~1000)
干预措施: Aspirin (Drug)
结局指标
主要结局
Time from randomization to the first occurrence of Stroke or systemic embolism
时间窗: Approximately 4 years
Stroke (Ischemic, hemorrhagic or undetermined type)
次要结局
- Time from randomization to the first occurrence of Myocardial Infarction (MI)(Approximately 4 years)
- Time from randomization to time of vascular death(Approximately 4 years)
研究者
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