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

Conditions

Diabetes with asymptomatic arterial disease Nutritional, Metabolic, Endocrine Diabetes

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, Prevention of Progression of Arterial Disease and Diabetes Study Group, Diabetes Registry Group, Royal College of Physicians Edinburgh.

2008-10-16572 citations

10.1136/bmj.a1840

Interventions

Aspirin 100 mg/day and antioxidant therapy, separately or together/placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed