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ISRCTN
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ISRCTN53295293
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DOI
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10.1186/ISRCTN53295293
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The Prevention Of Progression of Asymptomatic Diabetic Arterial Disease (a multicentre study)
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Scientific title
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Acronym
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POPADAD study
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Serial number at source
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G9534799
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Study hypothesis
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The aim of the trial is to evaluate whether aspirin and antioxidant therapy, either separately or together, are more effective than placebo in reducing the development of vascular events.
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Lay summary
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Ethics approval
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LREC/10/10/1996 MREC/98/0/104 11/02/1999
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Study design
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Double blind randomised and controlled, 2 x 2 factorial design
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes with asymptomatic arterial disease
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Participants - inclusion criteria
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1. Participants will be both Insulin-Dependent Diabetes Mellitus (IDDM) and Non Insulin-Dependent Diabetes Mellitus (NIDDM) patients of either sex, 40+ years of age
2. All patients will have ankle brachial pressure index (ABPI) of less than 0.98
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Participants - exclusion criteria
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1. Participants taking regular aspirin, antioxidant therapy
2. Evidence of symptomatic vascular disease
3. Serious physical illness such as cancer which may curtail life expectancy
4. Psychiatric illness (reported by GP)
5. Congenital heart disease
6. Pregnancy
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Anticipated start date
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01/08/1997
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1600
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Interventions
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Aspirin 100 mg/day and antioxidant therapy, separately or together/placebo
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Primary outcome measure(s)
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There are two hierarchical primary endpoints sought in this study:
1. Coronary heart disease and stroke death plus non-fatal stroke and myocardial infarction and above ankle amputation for critical limb ischaemia
2. Coronary heart disease death and fatal stroke
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Secondary outcome measure(s)
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1. All cause mortality
2. Non-fatal myocardial infarction
3. Other vascular events including coronary and peripheral arterial bypass surgery and/or angioplasty, development of angina, claudication, transient ischaemic attack or development of critical limb ischaemia
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18927173
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Contact name
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Prof
Jill
Belch
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Address
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Department of Medicine
Ninewells Hospital & Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 632457
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Fax
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+44 (0)1382 632333
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Email
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j.j.f.belch@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Research & Innovations Services
University of Dundee
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Tel
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+44 (0)1382 344000
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Fax
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+44 (0)1382 201604
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Email
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university@dundee.ac.uk
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Sponsor website:
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http://www.dundee.ac.uk/
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Date applied
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17/10/2000
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Last edited
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20/10/2008
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Date ISRCTN assigned
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17/10/2000
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