Action to Control Cardiovascular Risk in Diabetes (ACCORD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
First received: October 27, 1999
Last updated: February 7, 2014
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus
Coronary Disease
Drug: Hypoglycemic Agents
Drug: Intensive BP treatment
Drug: Fenofibrate + simvastatin
Drug: Standard glycemia control
Drug: Standard BP control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • First occurence of a major CVD event, specifically nonfatal heart attack, nonfatal stroke, or cardiovascular death (measured throughout the study) [ Time Frame: 5-1/2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • total mortality [ Time Frame: 5-1/2 years ] [ Designated as safety issue: Yes ]

Enrollment: 10251
Study Start Date: September 1999
Study Completion Date: December 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Intensive glycemia control
A strategy of intensive glycemia treatment to HbA1 less than 6%
Drug: Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
Active Comparator: 2: Standard glycemia control
A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
Drug: Standard glycemia control
A strategy of glycemia drugs for HbA1c 7%-7.9%
Experimental: 3: Intensive BP control
A strategy of BP treatment for SBP less than 120 mm Hg
Drug: Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Active Comparator: 4: Standard BP control
A strategy of BP treatment for SBP less than 140 mm Hg
Drug: Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg
Experimental: 5: Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
Drug: Fenofibrate + simvastatin
Blinded fenofibrate or placebo + simvastatin 20-40 mg/d

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000620

Locations
United States, Minnesota
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States, 55404
United States, New York
Columbia University
New York, New York, United States, 10027
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Tennessee
Veterans Affairs
Memphis, Tennessee, United States, 38104
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
Investigators
Study Director: Denise Simons-Morton, MD, PhD National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William Friedewald, MD Columbia University, New York, NY
Principal Investigator: Robert Byington, PhD Wake Forest University, Winston-Salem, NC
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000620     History of Changes
Other Study ID Numbers: 123
Study First Received: October 27, 1999
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Diabetes Mellitus, Non-Insulin-Dependent

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Hypertension
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Hypoglycemic Agents
Fenofibrate
Simvastatin
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014