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The Prevention Of Progression of Asymptomatic Diabetic Arterial Disease (a multicentre study)
DOI 10.1186/ISRCTN53295293
ClinicalTrials.gov identifier
EudraCT number
Public title The Prevention Of Progression of Asymptomatic Diabetic Arterial Disease (a multicentre study)
Scientific title
Acronym POPADAD study
Serial number at source G9534799
Study hypothesis 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.
Lay summary
Ethics approval LREC/10/10/1996 MREC/98/0/104 11/02/1999
Study design Double blind randomised and controlled, 2 x 2 factorial design
Countries of recruitment United Kingdom
Disease/condition/study domain Diabetes with asymptomatic arterial disease
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/08/1997
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material
Target number of participants 1600
Interventions Aspirin 100 mg/day and antioxidant therapy, separately or together/placebo
Primary outcome measure(s) 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
Secondary outcome measure(s) 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
Sources of funding Medical Research Council (UK)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18927173
Contact name Prof  Jill  Belch
  Address Department of Medicine
Ninewells Hospital & Medical School
  City/town Dundee
  Zip/Postcode DD1 9SY
  Country United Kingdom
  Tel +44 (0)1382 632457
  Fax +44 (0)1382 632333
  Email j.j.f.belch@dundee.ac.uk
Sponsor University of Dundee (UK)
  Address Research & Innovations Services
University of Dundee
  City/town Dundee
  Zip/Postcode DD1 4HN
  Country United Kingdom
  Tel +44 (0)1382 344000
  Fax +44 (0)1382 201604
  Email university@dundee.ac.uk
  Sponsor website: http://www.dundee.ac.uk/
Date applied 17/10/2000
Last edited 20/10/2008
Date ISRCTN assigned 17/10/2000
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