Influence of Rivaroxaban 2.5 mg Two Times a Day for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic Peripheral Arterial Disease (PAD) - a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Number of Participants Diagnosed with Major Limb Amputation (AMI) at 3 Months
研究概览
简要总结
The aim of the conducted research is to evaluate the protective effect of rivaroxaban (trade name of the Xarelto medicinal product), administered together with acetylsalicylic acid (ASA), in comparison with the effectiveness of using ASA alone, in relation to the distance of claudication and exercise tolerance in patients with PAD over a period of 3 months. At present, COMPASS results show that rivaroxaban vascular dose (2.5 mg twice daily) in combination with ASA (75-100 mg once daily) provides more effective cardiovascular protection (defined as cardiovascular death, vascular, myocardial infarction and stroke) compared to ASA alone. So far, however, no scientific studies have been carried out into account the effect of the drug on the progress of PAD and exercise tolerance in patients.
详细描述
EXISTING KNOWLEDGE AND MAIN ASSUMPTIONS OF THE PROJECT.
Atherosclerosis is the most common cause of peripheral artery disease (PAD). The first symptom of PAD is intermittent claudication (IC), which is characterized by the occurrence of pain, cramps, numbness, and discomfort in the lower limb muscles. They gradually intensify while walking, forcing the patient to stop. The symptoms are caused by continuous, specific physical effort and quickly disappear when it is stopped. The reduction of the possibility of walking leads to a decrease in the quality of life of patients and adds to other dangerous consequences of atherosclerosis, increased risk of cardiovascular incidents (myocardial infarction (MI), stroke, acute lower limb ischemia, Micker M et al. 2006).
Pharmacological treatment of patients with IC is aimed at modifying cardiovascular risk factors and improving the quality of life by alleviating pain and prolonging the claudication distance (Goszcz et al., 2009).
- New possibilities for the pharmacotherapy of patients with symptomatic PAD.
According to the adopted TASC (The Trans Atlantic Inter-Society Consensus), and its TASC II supplement concerning aspects of management and treatment of patients with chronic limb ischemia (CLI), drugs used in PAD are divided into nine groups: those with documented clinical effect used in IC (cilostazol and naphthydrofuryl), drugs with probable clinical effect used in IC (carnitine and propyl-L-carnitine), lipid-lowering drugs (statins), drugs with insufficiently proven clinical effects (penthoxyphilin), anticoagulants, L-arginine, 5-hydroxytryptamine (ketanserin) antagonism, buflomedil, and defibrotide. 2. Antiplatelet drugs
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD, the Fontaine classification II
排除标准
- •Severe heart failure with known ejection fraction <30% or NYHA class III or IV symptoms
- •High risk of bleeding
- •Stroke with one month or any history of hemorrhaging or lacunar stroke
- •Estimated glomerular filtration rate <15 ml/ml
- •Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy/, oral anticoagulant therapy/
- •The known non-cardiovascular disease that is associated with poor prognosis (i.n, metastatic cancer)
- •History of hypersensitivity or known contraindication for rivaroxaban, aspirin
- •Systemic treatment with strong inhibitors of CYP 3A4 as well as p-glycoprotein or strong inducers of CYP 3M
- •Any known hepatic disease associated with coagulopathy
- •Concurrent participation in another study with an investigational drug
- •Known contraindication to any study-related procedures* Concerns: Absolute contraindications to an exercise test
- •Respiratory failure
- •BMI above or equal 40
- •Musculoskeletal dysfunction preventing walking (e.g. amputations)
研究组 & 干预措施
Experimental: Rivaroxaban [2.5 mg] + Aspirin
Drug: Rivaroxaban 2.5 mg twice daily, tablet Drug: Aspirin 75-100 mg once daily, tablet
干预措施: Rivaroxaban (Drug)
Experimental: Rivaroxaban [2.5 mg] + Aspirin
Drug: Rivaroxaban 2.5 mg twice daily, tablet Drug: Aspirin 75-100 mg once daily, tablet
干预措施: Aspirin (Drug)
Active Comparator: Aspirin
Drug: Aspirin 75-100 mg once daily, tablet
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of Participants Diagnosed with Major Limb Amputation (AMI) at 3 Months
时间窗: 3 months
Number of participants diagnosed with major limb amputation defined as amputations due to a vascular event above the forefoot, or defined as minor amputation if involving the forefoot and digits.
Change From Baseline in the Distance of Intermittent Claudication (Δ Dch) at 3 Months
时间窗: 3 months
Change in the distance of intermittent claudication in the test according to Gardner's protocol
Change From Baseline in the Maximal Distance of Intermittent Claudication (Δ Dmax) at 3 Months
时间窗: 3 months
Change in the maximal distance of intermittent claudication in the test according to Gardner's protocol
Number of Participants Diagnosed with Stroke at 3 Months
时间窗: 3 months
Number of participants diagnosed with ischemic or hemorrhagic stroke
Number of Participants who Died from Cardiovascular Causes at 3 Months
时间窗: 3 months
Number of participants who died because of Cardiovascular causes
Number of Participants who Died from Any Cause at 3 Months
时间窗: 3 months
Number of Participants who died for any reason not related to accidents.
Number of Participants Diagnosed with Acute Limb Ischaemia (ALI) at 3 Months
时间窗: 3 months
Number of participants diagnosed with acute limb ischaemia definied as limb threatening ischaemia with evidence of acute arterial obstruction by radiological criteria or a new pulse deficit leading to an intervention (ie, surgery, thrombolysis, peripheral angioplasty, or amputation.
Number of Participants Diagnosed with Myocardial Infarction (MI) at 3 Months
时间窗: 3 months
Number of participants diagnosed with myocardial infarction
次要结局
未报告次要终点