Phase 3
N=10,251
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Atherosclerosis · Cardiovascular Diseases · Hypercholesterolemia · Hypertension · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00000620 ↗Enrolled (actual)
10,251
Serious AEs
2.4%
Results posted
Sep 2014
Primary outcome: 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. — 503; 543 participants — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anti-hyperglycemic Agents (Drug); Anti-hypertensive Agents (Drug); Blinded fenofibrate or placebo plus simvastatin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
503; 543 | 0.12 |
| PRIMARY First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. |
208; 237 | 0.20 |
| PRIMARY First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. |
291; 310 | 0.32 |
| SECONDARY Death From Any Cause in the Glycemia Trial. |
391; 327 | 0.02 sig |
| SECONDARY Stroke in the Blood Pressure Trial. |
36; 62 | 0.01 sig |
| SECONDARY First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. |
641; 667 | 0.30 |
Summary
The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest
- For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina)
- For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors
- HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)
Data sourced from ClinicalTrials.gov (NCT00000620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.