Outcomes of Rivaroxaban and Aspirin in Patients With Lower Extremity Peripheral Arterial Disease After Endovascular Revascularization.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- Patency
研究概览
简要总结
Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization
详细描述
Globally more than 200 million people suffer from peripheral artery disease (PAD), and the incidence is rising due to advancing age, high rates of smoking in certain regions of the world, and the rising incidence of type 2 diabetes.
PAD patients have wide-spread atherosclerosis and suffer a high risk of major cardiovascular (CV) events, with atherothrombosis as the underlying pathophysiologicmechanism. Symptomatic peripheral artery disease (PAD) is associated with a reduction in exercise capacity and quality of life and risk for tissue loss that is often treated with lower extremity revascularization (LER) to relieve symptoms and to prevent limb loss in a large portion of the population.
PAD is also associated with a heightened risk for major adverse cardiovascular and limb events.
LER is associated with a substantial increased risk of ischemic cardiovascular and limb events, including a 4-fold increased risk for acute limb ischemia (ALI), an ≈30% increased risk of myocardial infarction (MI), and an increased risk of rehospitalization after LER.
Observations from a large administrative database showed that patients with PAD after LER had an early heightened risk for ischemic limb events and a later increased risk for cardiovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 .
- •Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease.
- •Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization.
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- •Subject has provided written informed consent.
排除标准
- •Subject's age less than
- •Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
- •Imminent or foreseeable amputation.
- •Subject already had a major amputation on the affected extremity
- •Subject has emergent ischemic lesion [such as gas forming infection].
- •Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre- treatment.
- •Subject is not in the position to be primarily revascularized or refuses surgery.
- •Acute embolic ischemia.
结局指标
主要结局
Patency
时间窗: One year
Determination of patency of the target limb is essentially by measuring Ankle brachial Index(ABI)
次要结局
未报告次要终点
研究者
Ahmed Hassan Ahmed Elshimy
Doctor
Assiut University