The Prevention Of Progression of Asymptomatic Diabetic Arterial Disease (a multicentre study)

ISRCTN	ISRCTN53295293
DOI	https://doi.org/10.1186/ISRCTN53295293
Secondary identifying numbers	G9534799

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jill Belch
Scientific

Department of Medicine
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 632457
Email	j.j.f.belch@dundee.ac.uk

Study design	Double blind randomised and controlled, 2 x 2 factorial design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	POPADAD study
Study objectives	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(s)	LREC/10/10/1996 MREC/98/0/104 11/02/1999
Health condition(s) or problem(s) studied	Diabetes with asymptomatic arterial disease
Intervention	Aspirin 100 mg/day and antioxidant therapy, separately or together/placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aspirin and antioxidant therapy
Primary outcome measure	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 study start date	01/08/1997
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1600
Key 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
Key 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
Date of first enrolment	01/08/1997
Date of final enrolment	31/12/2006

Department of Medicine

Dundee
DD1 9SY
United Kingdom

University of Dundee (UK)
University/education

Research & Innovations Services
University of Dundee
Dundee
DD1 4HN
Scotland
United Kingdom

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	16/10/2008		Yes	No