Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants
NCT ID: NCT01037530
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
33 participants
INTERVENTIONAL
2010-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ramipril
Ramipril
5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Interventions
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Ramipril
5 mg/day for 2 weeks then 10 mg/day for 22 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Unlikely to be compliant with medication or follow up as determined by the recruiting institution.
* Pregnancy
* 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.\[56\].
* 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:
* Documented heart failure, left ventricular dysfunction or ejection fraction \<35% on previous echocardiography
* Uncontrolled hypertension, BP \> 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions
* Recent (\< 3months) myocardial infarction or stroke
* Chronic renal impairment (serum creatinine \> 250 micromol/l)
18 Years
80 Years
ALL
No
Sponsors
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Daniel Carradice
OTHER
Responsible Party
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Daniel Carradice
Clinical Lecturer
Principal Investigators
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Ian Chetter, MD, FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Hull
Locations
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Hull and East Yorkshire Hospitals
Hull, Yorkshire, United Kingdom
Countries
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References
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Shahin Y, Cockcroft JR, Chetter IC. Randomized clinical trial of angiotensin-converting enzyme inhibitor, ramipril, in patients with intermittent claudication. Br J Surg. 2013 Aug;100(9):1154-63. doi: 10.1002/bjs.9198.
Related Links
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Related publications
Other Identifiers
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2009-016600-23
Identifier Type: REGISTRY
Identifier Source: secondary_id
05102009
Identifier Type: -
Identifier Source: org_study_id