Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2005
Date assigned
01/09/2005
Last edited
09/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://ascend.medsci.ox.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Jane Armitage

ORCID ID

http://orcid.org/0000-0001-8691-9226

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

Nil known

ClinicalTrials.gov number

NCT00135226

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

Home

Trial type

Prevention

Patient information sheet

See additional files

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

Phase IV

Drug names

Aspirin, omega-3 fatty acids

Primary outcome measure

Current as of 07/05/2019:
1. The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as:
1.1. Non-fatal myocardial infarction; or
1.2. Non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or
1.3. Vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision [ICD-10] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage [I60], intracerebral hemorrhage [I61], and other non-traumatic intracranial hemorrhage [I62]).
Time frame: Randomised treatment phase during a mean of 7.4 years.
2. The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as:
2.1. Any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or
2.2. Sight-threatening eye bleeding; or
2.3. Any other serious bleeding episode
Time frame: Randomised treatment phase during a mean of 7.4 years.

From 26/05/2016 to 07/05/2019:
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).

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

Secondary outcome measures

Current as of 07/05/2019:
1. Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations).
Time frame: Randomised treatment phase during a mean of 7.4 years
2. Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up.
Time frame: Randomised treatment phase during a mean of 7.4 years

From 26/05/2016 to 07/05/2019:
1. Effect of aspirin versus placebo and separately omega-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)

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

Overall trial start date

14/03/2005

Overall trial end date

31/07/2037

Reason abandoned (if study stopped)

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

Total final enrolment

15480

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

https://www.ctsu.ox.ac.uk/

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

Trusts, charities, foundations (both publically funded and privately funded)

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

Planned publication in a high-impact peer reviewed journal in 2038.
Results will also be available on the study website https://ascend.medsci.ox.ac.uk/

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request. Procedures for accessing the data for this study are available at: https://www.ndph.ox.ac.uk/about/data-access-policy.

Intention to publish date

31/07/2038

Participant level data

Available on request

Basic results (scientific)

Results from the ASCEND trial can be found on the ASCEND website https://ascend.medsci.ox.ac.uk/ and at https://clinicaltrials.gov/ct2/show/results/NCT00135226

Publication list

2016 recruitment methods in: http://www.ncbi.nlm.nih.gov/pubmed/27296091
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29653635 [added 01/02/2019]
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30146932 [added 07/05/2019]
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30146931 [added 07/05/2019]

Publication citations

Editorial Notes

09/05/2019: The following changes were made to the trial record: 1. Publication and dissemination plan and IPD sharing statement added. 2. The overall trial end date was changed from 31/12/2017 to 31/07/2037. 07/05/2019: The following changes were made to the trial record: 1. The primary and secondary outcome measures were updated. 2. Added link to basic results (scientific). 3. Publication references added. 4. The total final enrolment number was added. 5. The participant information sheets have been uploaded. 01/02/2019: Publication reference added. 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