Contact information
Type
Scientific
Primary contact
Prof Jill Belch
ORCID ID
Contact details
Department of Medicine
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632457
j.j.f.belch@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9534799
Study information
Scientific title
Acronym
POPADAD study
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Diabetes with asymptomatic arterial disease
Intervention
Aspirin 100 mg/day and antioxidant therapy, separately or together/placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Aspirin and antioxidant therapy
Primary outcome measures
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 measures
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
Overall trial start date
01/08/1997
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1600
Participant 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
Recruitment start date
01/08/1997
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research & Innovations Services
University of Dundee
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344000
university@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18927173
Publication citations
-
Results
Belch J, MacCuish A, Campbell I, Cobbe S, Taylor R, Prescott R, Lee R, Bancroft J, MacEwan S, Shepherd J, Macfarlane P, Morris A, Jung R, Kelly C, Connacher A, Peden N, Jamieson A, Matthews D, Leese G, McKnight J, O'Brien I, Semple C, Petrie J, Gordon D, Pringle S, MacWalter R, , , , The prevention of progression of arterial disease and diabetes (POPADAD) trial: factorial randomised placebo controlled trial of aspirin and antioxidants in patients with diabetes and asymptomatic peripheral arterial disease., BMJ, 2008, 337, a1840.