Trial · NCT00000620
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
NCT00000620, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Action to Control Cardiovascular Risk in Diabetes (ACCORD). Trials, record NCT00000620. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00000620
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Action to Control Cardiovascular Risk in Diabetes (ACCORD)
- NCT number
- NCT00000620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10,251 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus, Coronary Disease
- Interventions
- Anti-hyperglycemic Agents, Anti-hypertensive Agents, Blinded fenofibrate or placebo plus simvastatin
- First posted
- 1999-10-28
- Last updated
- 2016-11-22
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | 4.9 years | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion. |
| Primary | First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | 4.7 years | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. |
| Primary | First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | 4.7 years | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. |
| Secondary | Death From Any Cause in the Glycemia Trial. | 4.9 years | Time to death from any cause. Secondary measure for Glycemia Trial. A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid). |
| Secondary | Stroke in the Blood Pressure Trial. | 4.7 years | Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. |
| Secondary | First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. | 4.7 years | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | 4.9 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | participants | NUMBER |
| SECONDARY | Death From Any Cause in the Glycemia Trial. | 4.9 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death. | participants | NUMBER |
| PRIMARY | First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | 4.7 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | participants | NUMBER |
| SECONDARY | Stroke in the Blood Pressure Trial. | 4.7 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke. | participants | NUMBER |
| PRIMARY | First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | 4.7 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | participants | NUMBER |
| SECONDARY | First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. | 4.7 years | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | Glycemia Trial: Intensive Control | 503 | participants | ||
| First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | Glycemia Trial: Standard Control | 543 | participants | ||
| Death From Any Cause in the Glycemia Trial. | Glycemia Trial: Intensive Control | 391 | participants | ||
| Death From Any Cause in the Glycemia Trial. | Glycemia Trial: Standard Control | 327 | participants | ||
| First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | BP Trial: Intensive Control | 208 | participants | ||
| First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | BP Trial: Standard Control | 237 | participants | ||
| Stroke in the Blood Pressure Trial. | BP Trial: Intensive Control | 36 | participants | ||
| Stroke in the Blood Pressure Trial. | BP Trial: Standard Control | 62 | participants | ||
| First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | Lipid Trial: Fenofibrate | 291 | participants | ||
| First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | Lipid Trial: Placebo | 310 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glycemia Trial: Intensive Control/BP Trial: Intensive Control | 1,178 | |
| Overall Study | STARTED | Glycemia Trial: Intensive Control/BP Trial: Standard Control | 1,193 | |
| Overall Study | STARTED | Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate | 1,374 | |
| Overall Study | STARTED | Glycemia Trial: Intensive Control/Lipid Trial: Placebo | 1,383 | |
| Overall Study | STARTED | Glycemia Trial: Standard Control/BP Trial: Intensive Control | 1,184 | |
| Overall Study | STARTED | Glycemia Trial: Standard Control/BP Trial: Standard Control | 1,178 | |
| Overall Study | STARTED | Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate | 1,391 | |
| Overall Study | STARTED | Glycemia Trial: Standard Control/Lipid Trial: Placebo | 1,370 | |
| Overall Study | COMPLETED | Glycemia Trial: Intensive Control/BP Trial: Intensive Control | 1,016 | |
| Overall Study | COMPLETED | Glycemia Trial: Intensive Control/BP Trial: Standard Control | 1,057 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events72
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 | Congestive heart failure | Cardiac disorders | Glycemia Trial: Intensive Control | 34 | 5,128 | |
| serious | Congestive heart failure | Cardiac disorders | Glycemia Trial: Standard Control | 12 | 5,123 | |
| serious | Bradycardia, tachycardia, atrial fibrillation | Cardiac disorders | Glycemia Trial: Intensive Control | 13 | 5,128 | |
| serious | Bradycardia, tachycardia, atrial fibrillation | Cardiac disorders | Glycemia Trial: Standard Control | 4 | 5,123 | |
| serious | Angina/chest pain | Cardiac disorders | Glycemia Trial: Intensive Control | 4 | 5,128 | |
| serious | Angina/chest pain | Cardiac disorders | Glycemia Trial: Standard Control | 5 | 5,123 | |
| serious | Myocardial infarction | Cardiac disorders | Glycemia Trial: Intensive Control | 4 | 5,128 | |
| serious | Myocardial infarction | Cardiac disorders | Glycemia Trial: Standard Control | 5 | 5,123 | |
| serious | Dizziness, hypotension, syncope | Vascular disorders | Glycemia Trial: Intensive Control | 19 | 5,128 | |
| serious | Dizziness, hypotension, syncope | Vascular disorders | Glycemia Trial: Standard Control | 17 | 5,123 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glycemia Trial: Intensive Control | ||
| Total, all-cause mortality | Glycemia Trial: Standard Control | ||
| Total, other adverse events | Glycemia Trial: Intensive Control | 0 | 0 |
| Total, other adverse events | Glycemia Trial: Standard Control | 0 | 0 |
| Total, serious adverse events | Glycemia Trial: Intensive Control | 137 | 5,128 |
| Total, serious adverse events | Glycemia Trial: Standard Control | 107 | 5,123 |
Source ClinicalTrials.gov
Papers128
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01HC095178 | PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITU-268995178-268095178 | BYINGTON, ROBERT | WAKE FOREST UNIVERSITY HEALTH SCIENCES | DIVISION OF EPIDEMIOLOGY AND CLINICAL APPLICATIONS | 1999 to 2006 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glycemia Trial: Intensive Control vs Glycemia Trial: Standard Control: Death From Any Cause in the Glycemia Trial. | Trial comparisons |
| BP Trial: Intensive Control vs BP Trial: Standard Control: First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. | Trial comparisons |
Glycemia Trial: Intensive Control vs Glycemia Trial: Standard Control: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | Trial comparisons |
| Lipid Trial: Fenofibrate vs Lipid Trial: Placebo: First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. | Trial comparisons |
| Lipid Trial: Fenofibrate vs Lipid Trial: Placebo: First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. | Trial comparisons |
| BP Trial: Intensive Control vs BP Trial: Standard Control: Stroke in the Blood Pressure Trial. | Trial comparisons |
| Glycemia Trial: Intensive Control vs Glycemia Trial: Standard Control: serious adverse events | 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT00000620
GET https://conductscience.org/api/trials/v1/NCT00000620/flow?page=2