A Multicentric Open-label Randomized Controlled Study for Evaluating the Improvement of Endothelial Function in Stage II Peripheral Arterial Obstructive Disease Patients Treated With Sulodexide + Conventional Treatment {CT] Vs CT Alone
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Change from baseline endothelial function after 6 months
研究概览
简要总结
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).
详细描述
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet therapy; plus ACE inhibitor; plus Statin in patients with cholesterol total level > 1,35 g/l) or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI < 0. 9).
Criteria for efficacy evaluation are the assessement of the improvement of the Digital Thermal monitoring between base line (day 1) and day 180 measured by Vendys® and the measurement of the correlation between the Digital Thermal monitoring and the following parameters at base line, day 90 and day 180:
- Von Willebrand factor blood level.
- Clinical assessment as per pain free walking distance and maximum walking distance, as measured by walking machine.
- Fibrinogen blood level. Also an assessment of the study medication observance (patient's compliance) will be done.
Safety assessment will be done through the collection of the adverse events occurred during the study.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent claudication.
- •A systolic ankle brachial index ABI <
- •An age of over 40 years
- •At least one cardiovascular risk factor (active or weaned Smoking, diabetes mellitus, hypertension, lipid disorders, obesity, and erectile dysfunction) or a history of coronary artery disease or transient ischemic stroke or established.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •withdrawal of informed consent
- •participation in another clinical trial with investigational drugs within the last 12 weeks or during the present trial period
- •history of hypersensitivity to the investigational/conventional drugs
- •Non claudicating patients and patients with critical ischemia
- •Arteritis of non-atherosclerotic origin
- •Patients treated with the oxalate or Naftidrofuryl Pentoxifiline Cilostazol or within 3 months that preceded the inclusion
- •Patients receiving other agents that alter the secretion of NO (such as Sildenafil and Tadalafil) less than 2 weeks before inclusion
- •Patients receiving a regimen based on nitrates or molsidomine or Bosentan
- •Patients receiving Anti Vitamin K medication (AVK)
- •Hemorrhagic accident dating less than 15 days before inclusion
- •Heparin treatment or any treatment by low molecular weight heparins during the study for a continuous period of more than 10 days or a cumulative time during the study for more than 21 days.
研究组 & 干预措施
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: Statin (Drug)
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: Antiplatelet Agents (Drug)
CT group
78 patients will be treated by conventional treatment : antiplatelet therapy + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: ACE inhibitor (Drug)
Sulodexide + CT group
78 patients will be treated by :
- Sulodexide (250ULS, twice daily , oral administration)
- Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: Sulodexide (Drug)
Sulodexide + CT group
78 patients will be treated by :
- Sulodexide (250ULS, twice daily , oral administration)
- Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: Statin (Drug)
Sulodexide + CT group
78 patients will be treated by :
- Sulodexide (250ULS, twice daily , oral administration)
- Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: Antiplatelet Agents (Drug)
Sulodexide + CT group
78 patients will be treated by :
- Sulodexide (250ULS, twice daily , oral administration)
- Conventional treatment : antiplatelet agents + ACE inhibitor +/- Statin in patients with cholesterol total level > 1,35 g/l
干预措施: ACE inhibitor (Drug)
结局指标
主要结局
Change from baseline endothelial function after 6 months
时间窗: between base line (day 1) and day 180
Assess the improvement of the Digital Thermal monitoring measured by Vendys®: evaluation of the improvement of Fingertip Digital Thermal Monitoring (DTM) and the detection of a significant change of the FT2 parameters as per Endothelix discriminative values provided by the manufacturer between day 1 and day 180 (±15 days).
次要结局
- Metric change of the walking distance(base line, day 90 and day 180:)
- Change in Von Willebrand Factor (VWF) level(base line, day 90 and day 180)
- Assessment of the study medication observance patient's compliance(180 days)
- Assessment of safety(180 days)