CTRI/2017/08/009566招募中4 期
INVestIgation of rheumatiC AF Treatment Using vitamin K antagonists, rivaroxaban or aspirin Studies - INVICTUS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 6,500
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
入选标准
- •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.
- •Superiority 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 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
- •b) In the absence of AF or Flutter, patients would be eligible in the presence
- •of any one of the following:
- •a. Left atrial enlargement >=5.5 cm OR
- •b. Left atrial spontaneous echo contrast OR
- •c. Left atrial thrombus OR
- •d. Frequent ectopic atrial activity ( >1000/24 hours) on Holter monitoring
排除标准
- •For both Non-inferiority and Superiority trials:
- •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
- •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
- •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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