Action To Control Cardiovascular Risk In Diabetes

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Complete Title of Study

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Study Acronym (The trial's abbreviation if there is one)

ACCORD

Principal Investigator, Co-investigators, and Collaborating Institutions

Study Director: Denise Simons-Morton, MD, PhD of the National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William Friedewald, MD of Columbia University, New York, NY
Principal Investigator: Robert Byington, PhD of Wake Forest University, Winston-Salem, NC

Overview of Trial

The goal of the ACCORD study was to evaluate the ability of intensive glycemic control, intensive blood pressure control, and multiple lipid management to prevent major cardiovascular events in 10,251 type 2 diabetes patients.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)

  • Atherosclerosis
  • Cardiovascular Diseases
  • Hypercholesterolemia
  • Hypertension
  • Diabetes Mellitus, Type 2
  • Coronary Disease

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here

Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)

Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)

  • Experimental: A strategy of intensive glycemia treatment to HbA1 less than 6%
  • Active Comparator: A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
  • Experimental: A strategy of BP treatment for SBP less than 120 mm Hg
  • Active Comparator: A strategy of BP treatment for SBP less than 140 mm Hg
  • Experimental: Blinded fenofibrate + simvastatin 20-40 mg/d

Primary Pre-Specified Endpoint

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]

Secondary Endpoints

Total mortality [Time Frame: 5-1/2 years]

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)

Exclusion Criteria

None reported

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)

None reported

Conclusions of the Investigators (Quote the investigators conclusions here)

None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)

None reported

Slides

None reported

Video Commentary

None reported

References (How to insert a reference)

  • Gerstein HC, Miller ME, Byington RP; et al. (2008). "Effects of intensive glucose lowering in type 2 diabetes". N. Engl. J. Med. 358 (24): 2545–59. PMID 18539917. doi:10.1056/NEJMoa0802743. 
  • Cushman WC, Grimm RH, Cutler JA; et al. (2007). "Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 44i–55i. PMID 17599425. doi:10.1016/j.amjcard.2007.03.005. 
  • Williamson JD, Miller ME, Bryan RN; et al. (2007). "The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods". Am. J. Cardiol. 99 (12A): 112i–122i. PMID 17599421. doi:10.1016/j.amjcard.2007.03.029. 
  • Sullivan MD, Anderson RT, Aron D; et al. (2007). "Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design". Am. J. Cardiol. 99 (12A): 90i–102i. PMID 17599429. doi:10.1016/j.amjcard.2007.03.027. 
  • Bonds DE, Kurashige EM, Bergenstal R; et al. (2007). "Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 80i–89i. PMID 17599428. doi:10.1016/j.amjcard.2007.03.026. 
  • Kingry C, Bastien A, Booth G; et al. (2007). "Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 68i–79i. PMID 17599427. doi:10.1016/j.amjcard.2007.03.025. 
  • Ginsberg HN, Bonds DE, Lovato LC; et al. (2007). "Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 56i–67i. PMID 17599426. doi:10.1016/j.amjcard.2007.03.024. 
  • Goff DC, Gerstein HC, Ginsberg HN; et al. (2007). "Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 4i–20i. PMID 17599424. doi:10.1016/j.amjcard.2007.03.002. 
  • Gerstein HC, Riddle MC, Kendall DM; et al. (2007). "Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial". Am. J. Cardiol. 99 (12A): 34i–43i. PMID 17599423. doi:10.1016/j.amjcard.2007.03.004. 
  • Buse JB, Bigger JT, Byington RP; et al. (2007). "Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods". Am. J. Cardiol. 99 (12A): 21i–33i. PMID 17599422. doi:10.1016/j.amjcard.2007.03.003. 
  • Chew EY, Ambrosius WT, Howard LT; et al. (2007). "Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE)". Am. J. Cardiol. 99 (12A): 103i–111i. PMID 17599420. doi:10.1016/j.amjcard.2007.03.028. 

External sites for further information (How to insert links)

None reported

Detailed information about the trial

Ages

40 years to 79 years

Gender (Indicate whether men, women or both were enrolled)

Both

Accepts Healthy Volunteers (Answer yes or no)

No

Enrollment Period (Study start and end date)

Study start date: September 1999

Estimated study completion date: June 2010

Primary completion date: June 2009

Recruitment Status (explanation)

Active, not recruiting

Enrollment (Total number of patients enrolled)

10251

Study Sponsor (e.g. Investigator initiated or company name)

National Heart, Lung, and Blood Institute (NHLBI)

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)

National Heart, Lung, and Blood Institute (NHLBI)

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.


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