EUCTR2014-005569-58-ES进行中（未招募）1 期
An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of Rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures - VOYAGER PAD
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
- 6,564
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
- •- Age >=50
- •- Documented moderate to severe symptomatic lower extremity peripheral artery occlusive disease
- •- Technically successful peripheral infra-inguinal revascularization within the last 7 days prior to 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 2210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4290
排除标准
- •- Patients undergoing revascularization for asymptomatic peripherial artery disease, mild claudication without functional limitation or major tissue loss (including severe ischemic ulcers or gangrene) of the index leg
- •- Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis
- •- Prior revascularization on the index leg within 8 weeks of the qualifying revascularization
- •- Planned dual antiplatelet therapy use for the qualifying revascularization procedure of clopidogrel in addition to Aspirin for >30 days after the qualifying revascularization procedure
- •- Planned dual antiplatelet therapy use for any other indication(s) with any P2Y12 antagonists in addition to Aspirin after the qualifying revascularization procedure
研究者
相似试验
进行中（未招募）
1 期
Efficacy and safety of rivaroxaban in reducing the risk of major thrombotic vascular events in subjects with peripheral artery disease undergoing peripheral revascularization procedures of the lower extremities.Peripheral artery diseaseMedDRA version: 20.0Level: LLTClassification code 10053375Term: Peripheral revascularizationSystem Organ Class: 100000004865EUCTR2014-005569-58-DEBayer AG6,500
进行中（未招募）
不适用
An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEAPatients with confirmed acute symptomatic pulmonary embolism with or without confirmed acute symptomatic deep vein thrombosis of the lower limbs.MedDRA version: 8.1Level: PTClassification code 10037377EUCTR2006-001786-42-EEsanofi-aventis recherche et développement3,200
进行中（未招募）
不适用
An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEAPatients with confirmed acute symptomatic pulmonary embolism with or without confirmed acute symptomatic deep vein thrombosis of the lower limbs.MedDRA version: 14.0Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2006-001786-42-PTsanofi-synthelabo recherche3,200
进行中（未招募）
不适用
An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEAEUCTR2006-001786-42-BEsanofi-aventis recherche & développement3,200
进行中（未招募）
1 期
An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEAPatients with confirmed acute symptomatic pulmonary embolism with or without confirmed acute symptomatic deep vein thrombosis of the lower limbs.MedDRA version: 8.1Level: PTClassification code 10037377Term: Pulmonary embolismEUCTR2006-001786-42-SKsanofi-aventis recherche & développement3,200