EUCTR2009-016600-23-GB进行中（未招募）1 期
A double blind, randomised, placebo controlled trial to study the clinical effectiveness of Angiotensin Converting Enzyme (ACE) inhibitors, ramipril,in patients with intermittent claudication - ACE Inhibitor Clinical Effectiveness in Claudicants
Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 0 人开始时间: 2010年6月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 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 comply with the study protocol
- •-Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Documented bilateral renal artery stenosis
- •- Unlikely to be compliant with medication or follow up as determined by the
- •recruiting institution.
- •- Pregnancy and breast feeding
- •- Women of child bearing age not having a method of contraception
- •- Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration > 2 weeks and/or a resting ankle pressure < 50mmHg- Grades II and III according to Rutherford et al(1997).
- •- 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
- •- Patients who had a recent (less than 3 months) angioplasty or bypass surgery
- •- 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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