PACTR202007518001972已完成3 期
INVestIgation of rheumatiC AF Treatment Using vitamin K antagonists, rivaroxaban or aspirin Studies
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Registry: Any patient with RVHD diagnosed by echocardiography (any age)
- •Non-Inferiority Trial:
- •1.RVHD diagnosed by echocardiography at any time prior to enrollment
- •2.Age =18
- •3.Increased risk of stroke by any of the following
- •a)CHA2DS2-VASc score = 2 OR
- •b)Moderate/Severe mitral stenosis with valve area =2.0 cm2 OR
- •c)Left atrial spontaneous echo contrast OR
- •d)Left atrial thrombus
- •4.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.
排除标准
- •1.Refusal to consent
- •2.Actively involved in any study that would compromise the protocol of INVICTUS Trial
- •3.Severe co-morbid condition with life expectancy < 1 year
- •4.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.
- •5.Likely to have valve replacement surgery within 6 months
- •6.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.
- •7.Contraindication to the study medication of the trial
- •a.Allergy to rivaroxaban
- •b.Allergy to VKAs ( non-inferiority trial)
- •c.Allergy to aspirin ( superiority trial)
- •8.Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) < 15 ml/min
- •9.Serious bleeding in the past six months or at high risk for bleeding
- •10.Moderate to severe hepatic impairment
- •11.Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy =100 mg per day are not excluded).
- •12.Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
- •13.Received an investigational drug in the past 30 days
- •14.Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
- •15.Women who are pregnant and/or breastfeeding
- •16.Women of child bearing age who do not use an effective form of birth control
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