INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,565
- 试验地点
- 139
- 主要终点
- Time from randomization to the first occurrence of vascular death or death of unknown cause, stroke, myocardial infarction 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, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.
详细描述
Non-Inferiority Trial of rivaroxaban versus VKAs: 4,500 patients
Inclusion Criteria:
-
RVHD diagnosed by echocardiography at any time prior to enrollment
-
Age ≥18
-
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 a) 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.
Treatment:
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 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.
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 (20 mg)
Rivaroxaban 20 mg od (n ~ 2250); 15 mg od (once daily) in patients with creatinine clearance (CrCl) 15-49 ml/min
干预措施: Rivaroxaban (20 mg) (Drug)
Vitamin K antagonists (VKA)
Any approved VKA in the participating country (n ~ 2250); VKA titrated to achieve an INR of 2.0-3.0
干预措施: Vitamin K antagonists (VKA) (Drug)
结局指标
主要结局
Time from randomization to the first occurrence of vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
时间窗: Approximately 4 years
Vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
次要结局
- Time from randomization to the first occurrence of composite of stroke or systemic embolism(Approximately 4 years)