EUCTR2014-005569-58-PT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）
- 发起方
- Bayer AG
- 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 atherosclerotic peripheral artery disease
- •a. clinically, by functional limitations in walking activity, ischemic rest pain, or ischemic ulceration,
- •b. anatomically, by imaging evidence of peripheral artery disease distal to the external iliac artery in the index leg within 12 months prior to or at the time of the qualifying revascularization
- •c. hemodynamically in either leg (within 12 months prior to, or at the time of, the qualifying revascularization) by:
- •? * an ABI = 0.80 or TBI = 0.60 for patients without a prior history of limb revascularization,
- •? * an ABI = 0.85 or TBI = 0.65 for patients with a prior history of limb revascularization;
- •- Technically successful peripheral revascularization distal to the external iliac artery (surgical and/or endovascular; for definition see Section 9.3.3) for symptomatic PAD within the last 10 days prior to
- •randomization
- •- Written informed consent by patient or his/her legal representative;
- •- Patient understands and is willing and able to comply with the study instructions and follow-up visit;
- •- Negative serum pregnancy test (in women of childbearing potential only);
- •- Women of reproductive potential must agree to use adequate contraception* when sexually active. This applies for the time period between signing of the informed consent form (ICF) to the last administration of study drug.
- •(*The definition of adequate contraception [with a failure rate of less than 1% per year] will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to: oral contraceptives, contraceptive injections, intrauterine device, double barrier method, male partner sterilization
- •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 PAD or mild claudication without functional limitation 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 10 days of the qualifying revascularization;
- •- Acute limb ischemia (ALI) within 2 weeks prior to the qualifying revascularization.
- •- Patients with major tissue loss (defined as significant ulceration/gangrene proximal to the metatarsal heads, i.e. heel or midfoot) in either leg;
- •Exclusion criteria related to concomitant and study treatment:
- •- Patients requiring treatment with ASA at doses >100 mg;
- •- Planned dual antiplatelet therapy (DAPT) use for the qualifying
- •revascularization procedure of clopidogrel in addition to ASA for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drugcoated products or devices), and is only allowed for up to 6 months for complex procedures or devices that in the investigator's opinion require longer use; see section 8.1 for further guidance on clopidogrel;
- •- Planned* use of any additional antiplatelet agent other than
- •clopidogrel and ASA after the qualifying revascularization procedure
- •(*This exclusion criterion refers to the clinical condition at the time of randomization. The use of DAPT with ASA plus clopidogrel, for new indication(s) occurring after randomization is permitted);
- •Exclusion criteria related to bleeding risks or systemic conditions:
- •- Medical history or active clinically significant bleeding, lesions, or conditions within the last 6 months prior to randomization, considered to be a significant risk for major bleeding (this may include current
- •medically confirmed gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, current or recent brain or spinal injury, known esophageal varices, vascular aneurysms of the large arteries or major intraspinal or intracerebral vascular abnormalities);
- •Other exclusion criteria:
- •- Previous (within 30 days) or concomitant participation in another clinical study with investigational product (s);
- •- Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site).
- •- Breast feeding
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