Trial · NCT00135226
ASCEND: A Study of Cardiovascular Events iN Diabetes
NCT00135226, Phase 4, Active not recruiting, University of Oxford; results first posted 2019-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ASCEND: A Study of Cardiovascular Events iN Diabetes. Trials, record NCT00135226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00135226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ASCEND: A Study of Cardiovascular Events iN Diabetes
- NCT number
- NCT00135226
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 15,480 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Diabetes Mellitus
- Interventions
- Aspirin, Omega-3 Ethyl Esters, Placebo Aspirin, Placebo Omega-3 Ethyl Esters
- First posted
- 2005-08-25
- Last updated
- 2025-05-28
- Other registries' IDs
- isrctn:ISRCTN60635500
- Results first posted
- 2019-04-26
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | 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 \[I62\]). |
| Primary | Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) | 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. |
| Secondary | Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Randomized treatment phase during a mean of 7.4 years | 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). |
| Secondary | Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only) | Randomized treatment phase during a mean of 7.4 years | 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. |
| Other | Number of Participants With Fatal Event: All-cause Mortality | Randomized treatment phase during a mean of 7.4 years | 'All-cause mortality' includes all recorded deaths. |
| Other | Number of Participants With Fatal Event: Coronary | 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). |
| Other | Number of Participants With Fatal Event: All Stroke | Randomized treatment phase during a mean of 7.4 years | 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). |
| Other | Number of Participants With Fatal Event: Other Vascular | Randomized treatment phase during a mean of 7.4 years | Fatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD). |
| Other | Number of Participants With Fatal Event: Cancer | Randomized treatment phase during a mean of 7.4 years | Fatal 'Cancer' events include any death attributed to cancer. |
| Other | Number of Participants With Fatal Event: Respiratory | Randomized treatment phase during a mean of 7.4 years | Fatal 'Respiratory' events include any death attributed to respiratory causes. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Randomized treatment phase during a mean of 7.4 years | A single participant may have had multiple events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only) | Randomized treatment phase during a mean of 7.4 years | Participants taking aspirin | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: All-cause Mortality | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: Coronary | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: All Stroke | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: Other Vascular | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: Cancer | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Fatal Event: Respiratory | Randomized treatment phase during a mean of 7.4 years | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | Aspirin | 658 | Participants | ||
| Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | Placebo Aspirin | 743 | Participants | ||
| Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | Omega-3 | 689 | Participants | ||
| Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) | Placebo Omega-3 | 712 | Participants | ||
| Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) | Aspirin | 314 | Participants | ||
| Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) | Placebo Aspirin | 245 | Participants | ||
| Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Aspirin | 833 | Participants | ||
| Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Placebo Aspirin | 936 | Participants | ||
| Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Omega-3 | 882 | Participants | ||
| Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations | Placebo Omega-3 | 887 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin + Omega-3 Ethyl Esters | 3,870 | |
| Overall Study | STARTED | Aspirin + Placebo Omega-3 Ethyl Esters | 3,870 | |
| Overall Study | STARTED | Placebo Aspirin + Omega-3 Ethyl Esters | 3,870 | |
| Overall Study | STARTED | Placebo Aspirin + Placebo Omega-3 Ethyl Esters | 3,870 | |
| Overall Study | COMPLETED | Aspirin + Omega-3 Ethyl Esters | 3,836 | |
| Overall Study | COMPLETED | Aspirin + Placebo Omega-3 Ethyl Esters | 3,835 | |
| Overall Study | COMPLETED | Placebo Aspirin + Omega-3 Ethyl Esters | 3,836 | |
| Overall Study | COMPLETED | Placebo Aspirin + Placebo Omega-3 Ethyl Esters | 3,834 | |
| Overall Study | NOT COMPLETED | Aspirin + Omega-3 Ethyl Esters | 34 | |
| Overall Study | NOT COMPLETED | Aspirin + Placebo Omega-3 Ethyl Esters | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Aspirin | 184 | 7,740 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Placebo Aspirin | 145 | 7,740 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Omega-3 | 156 | 7,740 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Placebo Omega-3 | 173 | 7,740 | |
| serious | Cardiac disorders | Cardiac disorders | Aspirin | 784 | 7,740 | |
| serious | Cardiac disorders | Cardiac disorders | Placebo Aspirin | 824 | 7,740 | |
| serious | Cardiac disorders | Cardiac disorders | Omega-3 | 812 | 7,740 | |
| serious | Cardiac disorders | Cardiac disorders | Placebo Omega-3 | 796 | 7,740 | |
| serious | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Aspirin | 5 | 7,740 | |
| serious | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Placebo Aspirin | 4 | 7,740 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin | 748 | 7,740 |
| Total, all-cause mortality | Placebo Aspirin | 792 | 7,740 |
| Total, all-cause mortality | Omega-3 | 752 | 7,740 |
| Total, all-cause mortality | Placebo Omega-3 | 788 | 7,740 |
| Total, other adverse events | Aspirin | 0 | 0 |
| Total, other adverse events | Placebo Aspirin | 0 | 0 |
| Total, other adverse events | Omega-3 | 0 | 0 |
| Total, other adverse events | Placebo Omega-3 | 0 | 0 |
| Total, serious adverse events | Aspirin | 5,264 | 7,740 |
| Total, serious adverse events | Placebo Aspirin | 5,321 | 7,740 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omega-3 vs Placebo Omega-3: Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only) | Trial comparisons |
| Aspirin vs Placebo Aspirin: Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only) | Trial comparisons |
| Aspirin vs Placebo Aspirin: Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) | Trial comparisons |
| Aspirin vs Placebo Aspirin: Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only) | Trial comparisons |
| Omega-3 vs Placebo Omega-3: Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00135226
GET https://conductscience.org/api/trials/v1/NCT00135226/registered?page=2