Diabetes MellitusPhase 4NCT00135226
ASCEND: A Study of Cardiovascular Events iN Diabetes
A Phase 4 study testing Aspirin and Omega-3 Ethyl Esters in people with Diabetes Mellitus, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Aspirin and Omega-3 Ethyl Esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15,480 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2005to 31 Jul 2037
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
- Currently prescribed aspirin, warfarin or any other blood thinning medication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Trial Service Unit, NDPH, University of Oxford
Oxford, OX3 7LF
About this study
Official title: 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
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.
Read the detailed description
The role of antiplatelet therapy (chiefly aspirin) for the secondary prevention of heart attacks and strokes is firmly established for many high-risk people with diagnosed arterial disease, and the proportional reductions in these cardiovascular events appear to be about one quarter, whether or not such patients have diabetes. But, most younger and middle-aged people with diabetes do not have manifest arterial disease - although they are still at significant cardiovascular risk - and yet few trials have tested aspirin in such individuals. As a result, there is substantial uncertainty about the role of aspirin for the prevention of heart attacks and strokes among apparently healthy people with diabetes, and only a small minority receives it.
There is consistent evidence from observational studies of lower rates of cardiovascular disease (particularly cardiac and sudden death) in people with higher intakes, or higher blood levels, of fish oils (omega-3 fatty acids). Trials in people who have survived a heart attack have shown modest, but potentially worthwhile, reductions in coronary events.
If ASCEND can reliably demonstrate that aspirin and/or fish oils safely reduce the risk of cardiovascular events and deaths in people with diabetes who do not have pre-existing arterial disease, then this would be relevant to some tens of millions of people world-wide (who are currently not receiving such therapy) and might save tens of thousands of lives each year.
The initial results (published 2018) showed that aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease, but it caused almost as many major bleeds and there was no effect on cancers. There was no significant difference in the risk of serious vascular events between those who were assigned to receive n-3 fatty acid supplementation and those who were assigned to receive placebo.
ASCEND will be conducting long-term follow-up for 20-years beyond the scheduled treatment period (which ended in 2017). We will collect relevant data from UK central health registries. This will be used to assess whether the balance of benefits versus hazards of aspirin observed within the main trial, relating to major vascular events such as heart attack or stroke, continue long-term or whether additional benefits emerge during longer-term follow-up.
In addition ASCEND will use this long-term post-trial follow-up to investigate further whether low-dose aspirin might protect against cancer. The main cancer analyses is planned to take place ~5-years after the end of the treatment period.
- Conditions
- Diabetes Mellitus
- Being tested
- Aspirin, Omega-3 Ethyl Esters, Placebo Aspirin, Placebo Omega-3 Ethyl Esters
- Keywords
- Diabetes Mellitus, Cardiovascular Disease, Aspirin, Omega-3 fatty acids, Primary prevention, Randomized Controlled Trial, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, n-3 fatty acid
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Omega-3 Ethyl EstersDrug
Also called n-3 fatty acid, Omacor
Placebo AspirinDrug
Placebo Omega-3 Ethyl EstersDrug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin + Omega-3 Ethyl Esters | Active comparator | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. Receives: Drug: Aspirin; Drug: Omega-3 Ethyl Esters |
| Aspirin + Placebo Omega-3 Ethyl Esters | Active comparator | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. Receives: Drug: Aspirin; Drug: Placebo Omega-3 Ethyl Esters |
| Placebo Aspirin + Omega-3 Ethyl Esters | Active comparator | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. Receives: Drug: Omega-3 Ethyl Esters; Drug: Placebo Aspirin |
| Placebo Aspirin + Placebo Omega-3 Ethyl Esters | Active comparator | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. Receives: Drug: Placebo Aspirin; Drug: Placebo Omega-3 Ethyl Esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 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.
Measured: 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
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).
Measured: Randomized treatment phase during a mean of 7.4 years
Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only)
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.
Measured: Randomized treatment phase during a mean of 7.4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startMar 2005
- Primary completion12 Mar 2018
- Study completion31 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Bayer, Medical Research Council, Solvay Pharmaceuticals, Abbott, Mylan, Health Data Research UK, Alzheimer's Research UK, The Macular Society
- Responsible party
- Sponsor
- Investigators
- Jane M Armitage, BSc, MBBS, MRCP, FFPH, Principal investigator, Clinical Trial Service Unit, NDPH, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135226
- Sponsor's protocol ID
- CTSUASCEND1
- Other IDs
- 60635500
- Status last verified
- May 2025
- First submitted
- 24 Aug 2005
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34962561Harper 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.
PubMed 37270201Sammons 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.
PubMed 37745288Parish 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.
PubMed 35393614Parish 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.
PubMed 31986094ASCEND 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.
PubMed 30146931ASCEND 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.
PubMed 30146932Bowman 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.
PubMed 29653635Sammons 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.
PubMed 38052385Sammons 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.
PubMed 38237868Petrucci 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.
PubMed 38385506Sammons 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.
PubMed 40010818Sammons 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.
PubMed 39501183Parish 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.
PubMed 36871000
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00135226
- Acronym / sponsor ID
- CTSUASCEND1
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Cardiovascular Disease, Aspirin, Omega-3 fatty acids, Primary prevention, Randomized Controlled Trial, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,480 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Heart Foundation, Bayer, Medical Research Council, Solvay Pharmaceuticals, Abbott, Mylan, Health Data Research UK, Alzheimer's Research UK, The Macular Society
- Study start
- Mar 2005
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 31 Jul 2037 (estimated)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The role of antiplatelet therapy (chiefly aspirin) for the secondary prevention of heart attacks and strokes is firmly established for many high-risk people with diagnosed arterial disease, and the proportional reductions in these cardiovascular events appear to be about one quarter, whether or not such patients have diabetes. But, most younger and middle-aged people with diabetes do not have manifest arterial disease - although they are still at significant cardiovascular risk - and yet few trials have tested aspirin in such individuals. As a result, there is substantial uncertainty about the role of aspirin for the prevention of heart attacks and strokes among apparently healthy people with diabetes, and only a small minority receives it.
There is consistent evidence from observational studies of lower rates of cardiovascular disease (particularly cardiac and sudden death) in people with higher intakes, or higher blood levels, of fish oils (omega-3 fatty acids). Trials in people who have survived a heart attack have shown modest, but potentially worthwhile, reductions in coronary events.
If ASCEND can reliably demonstrate that aspirin and/or fish oils safely reduce the risk of cardiovascular events and deaths in people with diabetes who do not have pre-existing arterial disease, then this would be relevant to some tens of millions of people world-wide (who are currently not receiving such therapy) and might save tens of thousands of lives each year.
The initial results (published 2018) showed that aspirin prevented serious vascular events in patients with diabetes who did not already have cardiovascular disease, but it caused almost as many major bleeds and there was no effect on cancers. There was no significant difference in the risk of serious vascular events between those who were assigned to receive n-3 fatty acid supplementation and those who were assigned to receive placebo.
ASCEND will be conducting long-term follow-up for 20-years beyond the scheduled treatment period (which ended in 2017). We will collect relevant data from UK central health registries. This will be used to assess whether the balance of benefits versus hazards of aspirin observed within the main trial, relating to major vascular events such as heart attack or stroke, continue long-term or whether additional benefits emerge during longer-term follow-up.
In addition ASCEND will use this long-term post-trial follow-up to investigate further whether low-dose aspirin might protect against cancer. The main cancer analyses is planned to take place ~5-years after the end of the treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aspirin + Omega-3 Ethyl Esters | Active comparator | Drug: Aspirin, Drug: Omega-3 Ethyl EstersParticipants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. |
| Aspirin + Placebo Omega-3 Ethyl Esters | Active comparator | Drug: Aspirin, Drug: Placebo Omega-3 Ethyl EstersParticipants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. |
| Placebo Aspirin + Omega-3 Ethyl Esters | Active comparator | Drug: Omega-3 Ethyl Esters, Drug: Placebo AspirinParticipants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. |
| Placebo Aspirin + Placebo Omega-3 Ethyl Esters | Active comparator | Drug: Placebo Aspirin, Drug: Placebo Omega-3 Ethyl EstersParticipants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
- Currently prescribed aspirin, warfarin or any other blood thinning medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin | Drug | Aspirin + Omega-3 Ethyl Esters, Aspirin + Placebo Omega-3 Ethyl Esters |
| Omega-3 Ethyl EstersAlso: n-3 fatty acid, Omacor | Drug | Aspirin + Omega-3 Ethyl Esters, Placebo Aspirin + Omega-3 Ethyl Esters |
| Placebo Aspirin | Drug | Placebo Aspirin + Omega-3 Ethyl Esters, Placebo Aspirin + Placebo Omega-3 Ethyl Esters |
| Placebo Omega-3 Ethyl Esters | Drug | Aspirin + Placebo Omega-3 Ethyl Esters, Placebo Aspirin + Placebo Omega-3 Ethyl Esters |
Primary outcome
Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)
Time frame: Randomized treatment phase during a mean of 7.4 years
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]).
Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)
Time frame: Randomized treatment phase during a mean of 7.4 years
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.
2 secondary outcomes
Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations
Time frame: Randomized treatment phase during a mean of 7.4 years
Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only)
Time frame: Randomized treatment phase during a mean of 7.4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34962561Harper 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.
- Background: PubMed 37270201Harper 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.
- Background: PubMed 37745288Sammons 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.
- Results publication: PubMed 35393614Parish 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.
- Results publication: PubMed 31986094Parish 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.
- Results publication: PubMed 30146931ASCEND 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.
- Results publication: PubMed 30146932ASCEND 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.
- Results publication: PubMed 29653635Bowman 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.
- Results publication: PubMed 38052385Sammons 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.
- Results publication: PubMed 38237868Sammons 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.
- Results publication: PubMed 38385506Petrucci 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.
- Results publication: PubMed 40010818Sammons 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.
- The study website for information about ASCEND: A Study of Cardiovascular Events iN DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane M Armitage, BSc, MBBS, MRCP, FFPH principal investigator
Clinical Trial Service Unit, NDPH, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Omega-3 Ethyl Esters in people with Diabetes Mellitus, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) (time frame: Randomized treatment phase during a mean of 7.4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135226, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.