E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermittent Claudication |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Can Ramipril which is an angiotensin converting enzyme inhibitor ( a medication mainly used for hypertension and heart failure) improve walking in patients with peripheral vascular disease in the legs? Or what we call intermittent leg claudicantion. We aim to investigate this by measuring the maximum walking distance the participant can walk. This will be done by a treadmill test. |
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E.2.2 | Secondary objectives of the trial |
We also aim to invetsigate the effects of Angiotensin Converting Enzyme Inhibitor (ACEI) -which is a drug called ramipril in our study- on: 1. The Ankle Brachial Pressure Index (ABPI) (which is an indicator of how narrow the arteries of the leg are).
2. Arterial effects: We will measure the stiffness of the arteries using a machine designed for this purpose and by doing a blood test. We will also study the effect of ramipril on the diameter of the brachial artery which is an artery in the elbow using ultrasound.
3. Endothelial function and markers of ischemia reperfusion: Endothelium means the lining of the arteries. The endothelium has markers in the blood which indicate if its functioning well or not. We want to know how ramipril affects these markers. This will be done by blood tests. A marker of ischemia reperfusion which is found is the Urine Albumin Creatinine Ratio. This is found to be elevated in patients with intermittent claudication post excercise. It basically indica |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-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
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E.4 | Principal exclusion criteria |
- 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
We aim to measure the maximum walking distance a participant can walk ( We have a ceiling of 10 minutes after which the treadmill test will be stopped) using a treadmill test in both the Ramipril group and the placebo group. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description |
We aim to investigate the clincial and cost effectiveness of ramipril in intermittent claudicants |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last participant undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |