Trial record 15 of 1639 for:
diabetes | NIH
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Collaborators:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
First received: October 27, 1999
Last updated: December 4, 2009
Last verified: February 2009
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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:
MedlinePlus related topics:
Atherosclerosis
Blood Sugar
Cholesterol
Coronary Artery Disease
Diabetes
Diabetes Medicines
Diabetes Type 2
High Blood Pressure
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | June 2010 |
| Estimated 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
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: | Robert P. Byington, MPH, PhD, FAHA, Wake Forest University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00000620 History of Changes |
| Other Study ID Numbers: | 123 |
| Study First Received: | October 27, 1999 |
| Last Updated: | December 4, 2009 |
| 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:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Atherosclerosis Cardiovascular Diseases Coronary Disease Coronary Artery Disease 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 May 21, 2013