ASCEND: A Study of Cardiovascular Events iN Diabetes

Summary

The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or death from vascular causes) in patients with diabetes who are not known to have occlusive arterial disease and to assess the effects on serious bleeding or other adverse events.

Conditions

• Diabetes Mellitus

Interventions

DRUG

Aspirin

DRUG

Omega-3 Ethyl Esters

DRUG

Placebo Aspirin

DRUG

Placebo Omega-3 Ethyl Esters

Sponsors & Collaborators

• British Heart Foundation

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• Medical Research Council

  collaborator OTHER_GOV

• Solvay Pharmaceuticals

  collaborator INDUSTRY

• Abbott

  collaborator INDUSTRY

• Mylan

  collaborator UNKNOWN

• Health Data Research UK

  collaborator UNKNOWN

• Alzheimer's Research UK

  collaborator UNKNOWN

• The Macular Society

  collaborator UNKNOWN

• University of Oxford

  lead OTHER

Principal Investigators

• Jane M Armitage, BSc, MBBS, MRCP, FFPH · Clinical Trial Service Unit, NDPH, University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-03-31

Primary Completion

2018-03-12

Completion

2037-07-31

Countries

• United Kingdom

Study Locations