Peripheral Arterial Disease Clinical Trial
— APOSA-PADOfficial title:
Allopurinol as a Possible Oxygen Sparing Agent During Exercise in Peripheral Arterial Disease
Verified date | May 2017 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peripheral arterial disease (PAD) is a common condition that arises due to the build up of
atheroma in the arteries supplying blood to the peripheral muscles and other tissues. This
imbalance between oxygen supply and demand becomes particularly apparent when patients with
the condition are walking. The pain and weakness they experience (mainly in the calf but
less commonly in the thigh) is known as intermittent claudication and resolves upon
cessation of exercise.
It is an important disease to study as it is (i) common (est. prevalence of symptomatic
intermittent claudication in Scotland of 4.5%) and (ii) those with it have a 1.6 times
higher relative risk of ischaemic heart disease. These patients also have a significantly
higher mortality than age-matched controls at around 12% per year.
There are two main aims of therapy - (i) to reduce the risk of cardiovascular events by way
of standard secondary prevention measures (smoking cessation, anti-platelet,
anti-hypertensive and cholesterol-lowering therapy, diabetic control) and (ii) to treat
symptoms.
Supervised exercise therapy has been shown to be beneficial in improving walking time and
distance in selected patients with leg pain from intermittent claudication with an overall
increase in walking distance of approximately 150 metres at three months.
There are numerous drug treatments available for consideration in PAD patients (mainly
cilostazol in the UK), but many of these have either undesirable side effects or no clear
evidence of benefit. The range of increase in walking distance on cilostazol was reported to
be a 50-76% increase over three months compared to 20% with placebo with some significant
improvements in Quality of Life (QOL) indicators, although with a significant number of
adverse effects (16% vs 8% on placebo) limiting therapy. The current cost (March 2010) is
£35.31/month.
Other options for therapy include angioplasty and bypass surgery. At present these are only
recommended for patients who fail to respond to medical therapy and have severely disabling
symptoms (in the absence of significant exercise-limiting comorbidities).
Status | Completed |
Enrollment | 50 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 85 Years |
Eligibility |
Inclusion Criteria: - stable peripheral arterial disease (demonstrated by having a reproducible pain free walking distance on 2 consecutive treadmill tests, i.e. less than 25% variance with the reason for termination of the treadmill test must be claudication pain only) Exclusion Criteria: - rest pain - childbearing potential - heart failure - any other exercise limiting cardiac disease - BP > 180/100 mHg - eGFR < 60 ml/min - liver disease - malignancy - already on allopurinol or had an adverse reaction to it - recent marked change in symptoms or recent (in the last six months) intervention for PAD - receiving treatment with either 6-mercaptopurine, azathioprine, warfarin, or theophylline |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ninewells Hospital | Dundee |
Lead Sponsor | Collaborator |
---|---|
University of Dundee | British Heart Foundation, NHS Tayside |
United Kingdom,
Robertson AJ, Struthers AD. A Randomized Controlled Trial of Allopurinol in Patients With Peripheral Arterial Disease. Can J Cardiol. 2016 Feb;32(2):190-6. doi: 10.1016/j.cjca.2015.05.010. Epub 2015 May 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Onset of claudication pain | Our primary endpoint will be the distance to onset of claudication pain at 24 weeks but we will also measure total exercise distance. | 24 weeks | |
Secondary | Quality of life | To see if allopurinol improves quality of life in patients with PAD. | 24 weeks | |
Secondary | Anti-oxidant effects | To investigate the anti-oxidant effects of allopurinol of patients with PAD. | 24 weeks |
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