ASCEND: A Study of Cardiovascular Events iN Diabetes
A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 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
2 other identifiers
interventional
15,480
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus
Started Mar 2005
Longer than P75 for phase_4 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2018
CompletedResults Posted
Study results publicly available
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2037
ExpectedMay 28, 2025
May 1, 2025
13 years
August 24, 2005
January 29, 2019
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)
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: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * 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 \[I62\]).
Randomized treatment phase during a mean of 7.4 years
Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)
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: * any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or * sight-threatening eye bleeding; or * any other serious bleeding episode.
Randomized treatment phase during a mean of 7.4 years
Secondary Outcomes (2)
Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations
Randomized treatment phase during a mean of 7.4 years
Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only)
Randomized treatment phase during a mean of 7.4 years
Other Outcomes (20)
Number of Participants With Fatal Event: All-cause Mortality
Randomized treatment phase during a mean of 7.4 years
Number of Participants With Fatal Event: Coronary
Randomized treatment phase during a mean of 7.4 years
Number of Participants With Fatal Event: All Stroke
Randomized treatment phase during a mean of 7.4 years
- +17 more other outcomes
Study Arms (4)
Aspirin + Omega-3 Ethyl Esters
ACTIVE COMPARATORParticipants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily.
Aspirin + Placebo Omega-3 Ethyl Esters
ACTIVE COMPARATORParticipants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily.
Placebo Aspirin + Omega-3 Ethyl Esters
ACTIVE COMPARATORParticipants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily.
Placebo Aspirin + Placebo Omega-3 Ethyl Esters
ACTIVE COMPARATORParticipants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Males or females with type 1 or type 2 diabetes mellitus.
- Aged ≥ 40 years.
- No previous history of vascular disease.
- No clear contra-indication to aspirin.
- No other predominant life-threatening medical problem.
You may not qualify if:
- Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
- Currently prescribed aspirin, warfarin or any other blood thinning medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- British Heart Foundationcollaborator
- Bayercollaborator
- Medical Research Councilcollaborator
- Solvay Pharmaceuticalscollaborator
- Abbottcollaborator
- Mylancollaborator
- Health Data Research UKcollaborator
- Alzheimer's Research UKcollaborator
- The Macular Societycollaborator
Study Sites (1)
Clinical Trial Service Unit, NDPH, University of Oxford
Oxford, OX3 7LF, United Kingdom
Related Publications (14)
Harper C, Mafham M, Herrington W, Staplin N, Stevens W, Wallendszus K, Haynes R, Landray MJ, Parish S, Bowman L, Armitage J. Comparison of the Accuracy and Completeness of Records of Serious Vascular Events in Routinely Collected Data vs Clinical Trial-Adjudicated Direct Follow-up Data in the UK: Secondary Analysis of the ASCEND Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2139748. doi: 10.1001/jamanetworkopen.2021.39748.
PMID: 34962561BACKGROUNDHarper C, Mafham M, Herrington W, Staplin N, Stevens W, Wallendszus K, Haynes R, Landray MJ, Parish S, Bowman L, Armitage J. Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data. Heart. 2023 Sep 13;109(19):1467-1472. doi: 10.1136/heartjnl-2023-322616.
PMID: 37270201BACKGROUNDSammons E, Bowman L, Stevens W, Buck G, Wallendszus K, Hammami I, Parish S, Armitage J; ASCEND Collaborative Group. ASCEND-Eye: Rationale, design and baseline characteristics for a sub-study of the ASCEND randomised trial, exploring the effects of aspirin and omega-3 fatty acids on diabetic retinopathy and age-related macular degeneration. Contemp Clin Trials Commun. 2023 Jul 5;35:101184. doi: 10.1016/j.conctc.2023.101184. eCollection 2023 Oct.
PMID: 37745288BACKGROUNDParish S, Mafham M, Offer A, Barton J, Wallendszus K, Stevens W, Buck G, Haynes R, Collins R, Bowman L, Armitage J. Effects of aspirin on dementia and cognitive function in diabetic patients: the ASCEND trial. Eur Heart J. 2022 Jun 1;43(21):2010-2019. doi: 10.1093/eurheartj/ehac179.
PMID: 35393614RESULTParish S, Mafham M, Offer A, Barton J, Wallendszus K, Stevens W, Buck G, Haynes R, Collins R, Bowman L, Armitage J; ASCEND Study Collaborative Group. Effects of Omega-3 Fatty Acid Supplements on Arrhythmias. Circulation. 2020 Jan 28;141(4):331-333. doi: 10.1161/CIRCULATIONAHA.119.044165. Epub 2020 Jan 27. No abstract available.
PMID: 31986094RESULTASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1529-1539. doi: 10.1056/NEJMoa1804988. Epub 2018 Aug 26.
PMID: 30146931RESULTASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Peto R, Baigent C, Collins R, Parish S, Armitage J. Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1540-1550. doi: 10.1056/NEJMoa1804989. Epub 2018 Aug 26.
PMID: 30146932RESULTBowman L, Mafham M, Stevens W, Haynes R, Aung T, Chen F, Buck G, Collins R, Armitage J; ASCEND Study Collaborative Group. ASCEND: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes. Am Heart J. 2018 Apr;198:135-144. doi: 10.1016/j.ahj.2017.12.006. Epub 2017 Dec 24.
PMID: 29653635RESULTSammons EL, Buck G, Bowman LJ, Stevens WM, Hammami I, Parish S, Armitage J; ASCEND Study Collaborative Group. ASCEND-Eye: Effects of Omega-3 Fatty Acids on Diabetic Retinopathy. Ophthalmology. 2024 May;131(5):526-533. doi: 10.1016/j.ophtha.2023.11.030. Epub 2023 Dec 3.
PMID: 38052385RESULTSammons EL, Buck G, Bowman LJ, Stevens WM, Hammami I, Parish S, Armitage J; ASCEND Study Collaborative Group. ASCEND-Eye: Effects of Aspirin on Diabetic Retinopathy. Ophthalmology. 2024 Jul;131(7):771-779. doi: 10.1016/j.ophtha.2024.01.018. Epub 2024 Jan 17.
PMID: 38237868RESULTPetrucci G, Buck GA, Rocca B, Parish S, Baigent C, Hatem D, Mafham M, Habib A, Bowman L, Armitage J, Patrono C. Thromboxane biosynthesis and future events in diabetes: the ASCEND trial. Eur Heart J. 2024 Apr 14;45(15):1355-1367. doi: 10.1093/eurheartj/ehad868.
PMID: 38385506RESULTSammons E, Bowman L, Stevens W, Buck G, Hammami I, Parish S, Armitage J; ASCEND-Eye Collaborative Group. Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes. BMJ Open. 2025 Feb 26;15(2):e090605. doi: 10.1136/bmjopen-2024-090605.
PMID: 40010818RESULTSammons EL, Buck G, Bowman LJ, Stevens WM, Hammami I, Parish S, Armitage J; ASCEND Study Collaborative Group. Effects of aspirin and omega-3 fatty acids on composite and subdomain scores from the NEI-VFQ-25 questionnaire: the ASCEND-Eye randomized controlled trial. BMC Ophthalmol. 2024 Nov 5;24(1):481. doi: 10.1186/s12886-024-03741-x.
PMID: 39501183RESULTParish S, Buck G, Aung T, Mafham M, Clark S, Hill MR, Collins R, Bowman L, Armitage J; ASCEND Study Collaborative Group. Effect of low-dose aspirin on urinary 11-dehydro-thromboxane B2 in the ASCEND (A Study of Cardiovascular Events iN Diabetes) randomized controlled trial. Trials. 2023 Mar 4;24(1):166. doi: 10.1186/s13063-023-07198-z.
PMID: 36871000DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Jane Armitage
- Organization
- Nuffield Department of Population Health
Study Officials
- PRINCIPAL INVESTIGATOR
Jane M Armitage, BSc, MBBS, MRCP, FFPH
Clinical Trial Service Unit, NDPH, University of Oxford
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
August 25, 2005
Study Start
March 1, 2005
Primary Completion
March 12, 2018
Study Completion (Estimated)
July 31, 2037
Last Updated
May 28, 2025
Results First Posted
April 26, 2019
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Access Criteria
- See URL
Proposals for substudies must be approved by the Steering Committee. Procedures for accessing the data for this study are available on: https://www.ndph.ox.ac.uk/about/data-access-policy.