| Trial ID: | L2106 |
| Source ID: | NCT00000620
|
| Associated Drug: |
Anti-Hyperglycemic Agents
|
| Title: |
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
|
| Acronym: |
ACCORD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00000620/results
|
| Conditions: |
Atherosclerosis|Cardiovascular Diseases|Hypercholesterolemia|Hypertension|Diabetes Mellitus, Type 2|Diabetes Mellitus|Coronary Disease
|
| Interventions: |
DRUG: Anti-hyperglycemic Agents|DRUG: Anti-hypertensive Agents|DRUG: Blinded fenofibrate or placebo plus simvastatin
|
| Outcome Measures: |
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., 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., 4.9 years|First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial., Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial., 4.7 years|First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial., Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants., 4.7 years | Secondary: Death From Any Cause in the Glycemia Trial., 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)., 4.9 years|Stroke in the Blood Pressure Trial., Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial., 4.7 years|First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial., Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants., 4.7 years
|
| Sponsor/Collaborators: |
Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|National Institute on Aging (NIA)|National Eye Institute (NEI)|Centers for Disease Control and Prevention
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
10251
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
1999-09
|
| Completion Date: |
2012-12
|
| Results First Posted: |
2014-09-15
|
| Last Update Posted: |
2016-11-22
|
| Locations: |
Minneapolis Medical Research Foundation, Minneapolis, Minnesota, 55404, United States|Columbia University, New York, New York, 10027, United States|Wake Forest University, Winston-Salem, North Carolina, 27106, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Veterans Affairs, Memphis, Tennessee, 38104, United States|University of Washington, Seattle, Washington, 98195, United States|McMaster University, Hamilton, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00000620
|
