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| ID | Type | Description | Link |
|---|---|---|---|
| 60635500 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| Bayer | INDUSTRY |
| Medical Research Council | OTHER_GOV |
| Solvay Pharmaceuticals |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin + Omega-3 Ethyl Esters | Active Comparator | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. |
|
| Aspirin + Placebo Omega-3 Ethyl Esters | Active Comparator | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. |
|
| Placebo Aspirin + Omega-3 Ethyl Esters | Active Comparator | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. |
|
| Placebo Aspirin + Placebo Omega-3 Ethyl Esters | Active Comparator | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug |
| ||
| Omega-3 Ethyl Esters |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| Randomized treatment phase during a mean of 7.4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fatal Event: All-cause Mortality | 'All-cause mortality' includes all recorded deaths. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Coronary |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane M Armitage, BSc, MBBS, MRCP, FFPH | Clinical Trial Service Unit, NDPH, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Service Unit, NDPH, University of Oxford | Oxford | OX3 7LF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34962561 | Background | 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. | |
| 37270201 |
| Label | URL |
|---|---|
| The study website for information about ASCEND: A Study of Cardiovascular Events iN Diabetes | View source |
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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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See URL
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Participants were randomized between June 2005 through July 2011. Follow-up continued until March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin + Omega-3 Ethyl Esters | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. Aspirin Omega-3 ethyl esters |
| FG001 | Aspirin + Placebo Omega-3 Ethyl Esters | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. Aspirin Placebo omega-3 ethyl esters |
| FG002 | Placebo Aspirin + Omega-3 Ethyl Esters | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. Placebo aspirin Omega-3 ethyl esters |
| FG003 | Placebo Aspirin + Placebo Omega-3 Ethyl Esters | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. Placebo aspirin Placebo omega-3 ethyl esters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin + Omega-3 | Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily. |
| BG001 | Aspirin + Placebo Omega-3 | Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals.
Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin | Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Jane Armitage | Nuffield Department of Population Health | +44 (0)1865 743743 | ascend@ndph.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 6, 2021 | Nov 2, 2022 | Prot_ICF_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2018 | Nov 22, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D015525 | Fatty Acids, Omega-3 |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
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| INDUSTRY |
| Abbott | INDUSTRY |
| Mylan | UNKNOWN |
| Health Data Research UK | UNKNOWN |
| Alzheimer's Research UK | UNKNOWN |
| The Macular Society | UNKNOWN |
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| Drug |
|
|
| Placebo Aspirin | Drug |
|
| Placebo Omega-3 Ethyl Esters | Drug |
|
| 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. | Randomized treatment phase during a mean of 7.4 years |
Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease).
| Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: All Stroke | Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction). | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Other Vascular | Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD). | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Cancer | Fatal 'Cancer' events include any death attributed to cancer. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Respiratory | Fatal 'Respiratory' events include any death attributed to respiratory causes. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Other Medical | Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: External Cause | Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Fatal Event: Unknown Cause | Any death for which the cause is not known. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Any Cancer | Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only) | Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Respiratory Cancer | Includes fatal and non-fatal cancers. Includes lung and larynx cancer. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Genitourinary Cancer | Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Hematological Cancer | Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Breast Cancer | Includes fatal and non-fatal cancers. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Melanoma | Includes fatal and non-fatal melanomas. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Other Cancer | Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known). | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Unspecified Cancer | Includes fatal and non-fatal cancers of unknown type. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only) | Includes fatal and non-fatal events. | Randomized treatment phase during a mean of 7.4 years |
| Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only) | Includes fatal and non-fatal events, excludes atrial fibrillation. | Randomized treatment phase during a mean of 7.4 years |
| Background |
| Harper 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. |
| 37745288 | Background | Sammons 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. |
| 35393614 | Result | Parish 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. |
| 31986094 | Result | Parish 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. |
| 30146931 | Result | ASCEND 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. |
| 30146932 | Result | ASCEND 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. |
| 29653635 | Result | Bowman 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. |
| 38052385 | Result | Sammons 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. |
| 38237868 | Result | Sammons 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. |
| 38385506 | Result | Petrucci 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. |
| 40010818 | Result | Sammons 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. |
| 39501183 | Result | Sammons 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. |
| 36871000 | Derived | Parish 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. |
| BG002 | Placebo Aspirin + Omega-3 | Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily. |
| BG003 | Placebo Aspirin + Placebo Omega-3 | Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body-mass index (kg/m²) | The body-mass index (the weight in kilograms divided by the square of the height in meters) was based on values for weight and height that were reported by the participants. | Count of Participants | Participants |
|
| Body-mass index (mean) | Mean | Standard Deviation | kg/m² |
|
| Smoking status | Count of Participants | Participants |
|
| Treated hypertension | Participant reported hypertension | Count of Participants | Participants |
|
| Aspirin use prior to screening | Count of Participants | Participants |
|
| Type of diabetes | The presence of type 2 diabetes was based on a broad clinical definition involving the age of the participant at the diagnosis of diabetes, the use of insulin within 1-year after diagnosis, and the body-mass index. | Count of Participants | Participants |
|
| Duration of diabetes (years) | Count of Participants | Participants |
|
| Duration of diabetes (years) | Median | Inter-Quartile Range | years |
|
| Systolic blood pressure (mmHg) | Count of Participants | Participants |
|
| Systolic blood pressure (mean) | Mean | Standard Deviation | mmHg |
|
| Vascular risk score | We categorized the predicted 5-year risk of serious vascular event (including transient ischemic attack) without the use of aspirin or n-3 fatty acids as follows: low risk as less than 5%, moderate risk as 5% to less than 10%, and high risk as 10% or more. | Count of Participants | Participants |
|
| OG001 | Placebo Aspirin | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm |
| OG002 | Omega-3 | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm |
| OG003 | Placebo Omega-3 | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm |
|
|
|
| Primary | 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:
| Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Secondary | 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). | A single participant may have had multiple events. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Secondary | 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. | Participants taking aspirin | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: All-cause Mortality | 'All-cause mortality' includes all recorded deaths. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Coronary | Fatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease). | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: All Stroke | Fatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction). | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Other Vascular | Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD). | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Cancer | Fatal 'Cancer' events include any death attributed to cancer. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Respiratory | Fatal 'Respiratory' events include any death attributed to respiratory causes. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Other Medical | Fatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: External Cause | Fatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Fatal Event: Unknown Cause | Any death for which the cause is not known. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Any Cancer | Incidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only) | Includes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Respiratory Cancer | Includes fatal and non-fatal cancers. Includes lung and larynx cancer. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Genitourinary Cancer | Includes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Hematological Cancer | Includes fatal and non-fatal cancers. Includes leukaemia and lymphoma. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Breast Cancer | Includes fatal and non-fatal cancers. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Melanoma | Includes fatal and non-fatal melanomas. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Other Cancer | Includes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known). | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Unspecified Cancer | Includes fatal and non-fatal cancers of unknown type. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only) | Includes fatal and non-fatal events. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only) | Includes fatal and non-fatal events, excludes atrial fibrillation. | Posted | Count of Participants | Participants | Randomized treatment phase during a mean of 7.4 years |
|
|
|
|
| 748 |
| 7,740 |
| 5,264 |
| 7,740 |
| 0 |
| 0 |
| EG001 | Placebo Aspirin | Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm | 792 | 7,740 | 5,321 | 7,740 | 0 | 0 |
| EG002 | Omega-3 | Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm | 752 | 7,740 | 5,344 | 7,740 | 0 | 0 |
| EG003 | Placebo Omega-3 | Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm | 788 | 7,740 | 5,241 | 7,740 | 0 | 0 |
| Cardiac disorders | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | MedDRA (14.0) | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | MedDRA (14.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (14.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Immune system disorders | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (14.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Social circumstances | Social circumstances | MedDRA (14.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| 1.00 |
| 2-Sided |
| 95 |
| 0.91 |
| 1.09 |
| Other |
| 0.95 |
| 2-Sided |
| 95 |
| 0.86 |
| 1.05 |
| Other |
| 0.79 |
| 2-Sided |
| 95 |
| 0.61 |
| 1.02 |
| Other |
| 0.94 |
| 2-Sided |
| 95 |
| 0.59 |
| 1.50 |
| Other |
| 0.80 |
| 2-Sided |
| 95 |
| 0.57 |
| 1.12 |
| Other |
| 0.95 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.12 |
| Other |
| 0.93 |
| 2-Sided |
| 95 |
| 0.68 |
| 1.28 |
| Other |
| 1.26 |
| 2-Sided |
| 95 |
| 1.00 |
| 1.59 |
| Other |
| 0.77 |
| 2-Sided |
| 95 |
| 0.41 |
| 1.45 |
| Other |
| 0.75 |
| 2-Sided |
| 95 |
| 0.17 |
| 3.31 |
| Other |
| 1.00 |
| 2-Sided |
| 95 |
| 0.91 |
| 1.10 |
| Other |
| 1.04 |
| 2-Sided |
| 95 |
| 0.79 |
| 1.37 |
| Other |
| 1.07 |
| 2-Sided |
| 95 |
| 0.91 |
| 1.25 |
| Other |
| 1.17 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.58 |
| Other |
| 1.14 |
| 2-Sided |
| 95 |
| 0.86 |
| 1.52 |
| Other |
| 1.02 |
| 2-Sided |
| 95 |
| 0.70 |
| 1.48 |
| Other |
| 0.72 |
| 2-Sided |
| 95 |
| 0.42 |
| 1.22 |
| Other |
| 0.78 |
| 2-Sided |
| 95 |
| 0.46 |
| 1.31 |
| Other |