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
- Conditions
- Intermittent Claudication
- Registration Number
- EUCTR2009-016600-23-GB
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
-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
- 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method