EUCTR2012-005449-19-GB进行中（未招募）1 期
A double-blind, randomised controlled trial of percutaneous transluminal angioplasty (PTA) & Ramipril versus PTA & placebo in the management of intermittent claudication (IC) - An RCT of Ramipril and PTA in Intermittent Claudication
Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 52 人开始时间: 2013年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients listed for elective femoropopliteal PTA for intermittant claudication due to peripheral artery disease
- •-Patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months.
- •-Patients with ABPI < 0.9 at rest at least in one leg.
- •-BP = 160/90 and a stable medication regimen for the last 6 months.
- •-Able to give informed consent
- •-Able to comply with study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Documented bilateral renal artery stenosis
- •Diabetes Mellitus types 1 or 2
- •Unlikely to be compliant with medication or follow up as determined by the recruiting institution.
- •Patients who had a recent (less than 3 months) angioplasty or bypass surgery
- •Pregnancy and breast feeding
- •Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration > 2 weeks and/or a resting ankle pressure < 50mmHg (grades IV, V and VI according to Rutherford et al 1997).
- •Patients who had a recent (less than 3 months) angioplasty or bypass surgery
- •Patients who are unable to perform a treadmill test due to a limiting heart, respiratory or arthritic disease.
- •History of angioneurotic oedema
- •Currently taking ACE inhibitor or Angiotensin receptor blocker
- •Contraindication to ACE inhibitor
- •History of ACE inhibitor intolerance
- •A creatinine rise of > 30% from baseline and/or Potassium > 5.9 mmol/l
- •Unwillingness to participate.
- •Level 1 evidence for ACE inhibitor treatment, including:
- •a) Documented heart failure, left ventricular dysfunction or ejection fraction <35% on previous echocardiography
- •b) uncontrolled hypertension, BP > 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions
- •c) Recent (< 3months) myocardial infarction or stroke
- •d) Chronic renal impairment (serum creatinine > 250 micromol/l)
研究者
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