Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2005
Date assigned
01/09/2005
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctsu.ox.ac.uk/ascend/

Contact information

Type

Scientific

Primary contact

Prof Jane Armitage

ORCID ID

Contact details

ASCEND Office
CTSU (Clinical Trial Service Unit)
Richard Doll Building
University of Oxford
Old Road Campus
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 743810
jane.armitage@ctsu.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTSU ASCEND 1

Study information

Scientific title

A randomised 2 x 2 factorial study of aspirin versus placebo, and of omega-3 fatty acid supplementation versus placebo, for primary prevention of cardiovascular events in people with diabetes

Acronym

ASCEND

Study hypothesis

To determine whether 100 mg daily aspirin versus placebo and/or supplementation with 1 g daily omega-3 fatty acids or placebo prevents 'serious vascular events' (i.e. non-fatal heart attack, non-fatal stroke 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.

Ethics approval

North West Multi-centre Research Ethics Committee, 29/12/2003, ref: 03/8/087. Amendments approved 28/06/2004, ref: CTSUASCEND1-1 –version 7, 01/03/2007, ref: CTSUASCEND2 Version 8.0_010207, 23/05/2007, ref: CTSUASCEND3 Version 8.0_010207 and 08/07/2008, ref: CTSUASCEND4, version 8.0_010207, 2008-06-10.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.ctsu.ox.ac.uk/ascend/ASCEND_patientinfo.pdf

Condition

Diabetes (type 1 & 2)

Intervention

100 mg daily aspirin versus placebo and/or supplementation with 1 g daily omega-3 fatty acids or placebo.

Intervention type

Drug

Phase

Not Applicable

Drug names

Aspirin, omega-3 fatty acid

Primary outcome measures

As of 26/05/2016:
Effect of aspirin versus placebo and separately omega-3 fatty acids versus placebo on serious vascular events or TIA (defined as the combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage, or TIA) at the end of the scheduled treatment period (average of 7.5 years).

Previous:
The combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage

Secondary outcome measures

As of 26/05/2016:
1. Effect of aspirin versus placebo and separately omerga-3 fatty acids versus placebo on serious vascular events in various prognostic groups at the end of the scheduled treatment period (average of 7.5 years)
2. Effect of aspirin versus placebo and separately omega-3 fatty acids versus placebo on cerebral haemorrhage at the end of the scheduled treatment period (average of 7.5 years)

Previous
1. Serious vascular event in various prognostic subgroups
2. Cerebral haemorrhage

Overall trial start date

14/03/2005

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female with diabetes (Type 1 or 2)
2. Aged greater than or equal to 40 years
3. No previous history of vascular disease
4. No clear contra-indication to aspirin
5. No other predominant life-threatening medical problem

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15,000

Participant exclusion criteria

The following point has been amended as of 11/02/2009:
2. Currently prescribed warfarin

Initial information at time of registration:
1. Definite history of myocardial infarction, stroke or arterial revascularisation procedure
2. Currently prescribed aspirin, warfarin or any other blood thinning medication

Recruitment start date

14/03/2005

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ASCEND Office
Clinical Trial Service Unit (CTSU) Richard Doll Building University of Oxford Old Road Campus Headington
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
ascend@ctsu.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

British Heart Foundation (BHF) (UK) (ref: Special Project No. SP/03/002; Grant No. PG/05/013/18296)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

Bayer Schering Pharma AG (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Solvay Pharmaceuticals GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27296091

Publication citations

Additional files

Editorial Notes

15/06/2016: Publication reference added. 11/02/2009: this record was updated to include amended trial dates. The initial trial dates at the time of registration were: Initial overall trial start date: 01/03/2005 Initial overall trial end date: 01/03/2011