Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/10/2000
Date assigned
17/10/2000
Last edited
20/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dundee.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes