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

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

Primary study design	Interventional
Study design	Double blind randomised and controlled, 2 x 2 factorial design
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aspirin and antioxidant therapy
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
Key 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
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1276
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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