Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Restenosis of the treated infrapopliteal artery
研究概览
简要总结
This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.
详细描述
This study is a multicentre, parallel-group, prospective, randomized open-label, blinded-endpoint adjudication, proof-of-concept, and exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once-daily for 12 months. In the control group, aspirin 100 mg once-daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age>18 years old.
- •Negative serum pregnancy test (in women of childbearing only).
- •Patients submitted to endovascular procedures below-the-knee by not exclusively.
- •Patient understands and is willing and able to comply with the study instructions and follow-up visit.
- •More than 70% stenosis or occlusion of the three distal arteries including or not the tibiofibular trunk (TFT).
- •Tissue loss (Rutherford 5).
- •One or more patent vessel of pedal arch.
排除标准
- •TASC II D femoral and/or popliteal occlusion.
- •Life expectancy less than 1 year.
- •Allergy or contraindication to apixaban treatment.
- •Allergy or contraindication to dual antiplatelet treatment.
- •Creatinine clearance less than 30mL/min.
- •Planned major amputation before procedure.
- •Hybrid procedure (open and endovascular).
- •Use of fibrinolytic in the past 10 days.
- •Known HIV infection.
- •Liver disease (acute or chronic hepatitis and cirrhosis).
- •Drug addiction or alcohol abuse 12 months before the randomization.
- •Concomitant medications thatinhibit the CYP 3A4 cytochrome and P glycoprotein (ketoconazole, Iitraconazole, ritonavir).
- •Platelets count inferior to 100x109/L.
- •INR more than 1.
- •History or condition with high risk of bleeding: Eg. Trauma within 30 days before randomization, gastrointestinal bleeding 6 month before the randomization, intra-ocular, spinal, intra-articular bleeding (any time before), AV malformation, cerebral aneurysm and hypertension without control.
研究组 & 干预措施
Control group
Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
干预措施: Clopidogrel 75mg (Drug)
Control group
Aspirin 100 mg (oral, once-daily) for 1 year plus Clopidogrel 75 mg (oral, once-daily) for 3 months.
干预措施: ASA (Drug)
Apixaban group
Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
干预措施: Apixaban (Drug)
Apixaban group
Apixaban 2.5 mg (oral, twice daily) for 1 year plus Aspirin 100 mg (oral, once-daily) for 1 year.
干预措施: ASA (Drug)
结局指标
主要结局
Restenosis of the treated infrapopliteal artery
时间窗: 12 months
Number of patients with absence of flow or \>2.4 sistolic index obtained by Duplex Scan
Clinical driven-target lesion revascularization
时间窗: 12 months
Number of patients who was submitted by reintervention of the treated infrapopliteal artery based on the clinical status
Major amputation
时间窗: 12 months
Number of patients who underwent amputation of the leg above the ankle
Major cardiovascular events
时间窗: 12 months
Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death
次要结局
- Healing(12 months)
- Bleeding(12 months)