2024-513363-15-01招募中4 期
CLEAR-PATH A randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty
Universitair Medisch Centrum Utrecht19 个研究点 分布在 1 个国家目标入组 1,696 人开始时间: 2024年7月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,696
- 试验地点
- 19
- 主要终点
- The primary endpoint is all-cause death and the occurence of cardiovascular adverse events after 1 year: (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.
研究概览
简要总结
To assess whether and to what extent DAPT is superior to SAPT, in reducing the combined endpoint of all-cause death, MACE and MALE within one-year follow-up in PAD patients who underwent EVR.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Lesions of the iliac, femoropopliteal, and/or below-the-knee (BTK) arteries;
- •At least one TASC lesion;
- •Rutherford (1-6) classes with an indication for an endovascular intervention
- •Proficient understanding of the consequences of enrolment by the patient
- •Written informed consent by the patient;
- •Age ≥ 45 years
- •And eligibility of lesions for;
- •Percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines, or;
- •Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA, or;
- •A reintervention within 2 months due to a phased treatment.
排除标准
- •Acute (limb) ischemia
- •Patients who are pregnant/contemplating pregnancy/nursing.
- •Patients requiring dialysis
- •Patients with liver failure and at least one of the following criteria;
- •elevated INR value, or;
- •portal hypertension, or;
- •thrombocytopenia <50x10^9/L, or;
- •INR, portal tension, or platelet count are unknown.
- •Reported intolerance or hypersensitivity to the study medications
- •Use of anticoagulant therapy (DOACs or coumarin)
- •Use of non-steroidal anti-inflammatory drugs >2 weeks which cannot be discontinued
- •Patients incompetent of understanding the consequences of enrolment in the trial
- •Patients with a reintervention due to restenosis/reocclusion within 2 months
- •Patients with a hybrid procedure other than endarterectomy of the common femoral artery such as femoral bypass
- •Patients with coagulopathy
- •Patients with a peptic ulcer confirmed by an esophagogastroduodenoscopy in their medical history
结局指标
主要结局
The primary endpoint is all-cause death and the occurence of cardiovascular adverse events after 1 year: (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.
The primary endpoint is all-cause death and the occurence of cardiovascular adverse events after 1 year: (indication for) re-intervention due to any restenosis or re-occlusion or due to acute limb ischemia, the occurence of any amputation, cerebrovascular event, myocardial infarction, or cardiovascular death.
次要结局
- The secondary endpoint is the occurence of all and major bleeding (following the TIMI bleeding classification and BARC criteria), major adverse cardiovascular events (MACE), and major adverse limb events (MALE). CYP2C19 polymorphisms will be determined to examine if non-responsiveness to clopidogrel predicts outcome.
研究者
Wetenschapsbureau
Scientific
Universitair Medisch Centrum Utrecht
研究点 (19)
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