Allopurinol as a possible oxygen sparing agent during exercise in peripheral arterial disease: a double-blind, placebo-controlled, parallel group study

niversity of Dundee (UK)0 个研究点目标入组 50 人开始时间: 2010年10月25日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Men and women age 35-85 years suffering from PAD. PAD will be defined as:
•1.1. Claudication defined as leg pain on walking and disappearing within 10 minutes on standing and of presumed atherosclerotic origin
•1.2. An ankle brachial pressure index (ABPI) of <0.90 on the worst leg at rest
•2. Stable disease demonstrated by having a reproducible pain free walking distance on 2 consecutive treadmill tests, i.e. less than 25% variance. The reason for termination of the test must be claudication pain only. All treadmill tests will be done at a speed of 3.2 km/h (= 2 mph), as is standard practice in PAD trials. The incline will begin at 0% and increase in grade of 2% every 2 minutes. This is the standard Skinner-Gardner protocol (Angiology 1992, 43(8): 661-671).

•1. Rest pain
•2. Childbearing potential
•3. Heart failure
•4. Any other exercise limiting cardiac disease
•5. BP >180/100 mHg
•6. eGFR <60 ml/min
•7. Liver disease
•8. Malignancy
•9. Already on allopurinol or had an adverse reaction to it.
•10. Participants who have had a recent marked change in symptoms or recent (in the last six months) intervention for PAD
•11. Participants receiving treatment which is contraindicated with the study treatment
•11.1. 6-mercaptopurine
•11.2. Azathioprine
•11.3. Warfarin
•11.4. Theophylline

发起方

niversity of Dundee (UK)