Action To Control Cardiovascular Risk In Diabetes

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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Phase I Trials

These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.

Phase II Trials

Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.

Phase III Trials

Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.

Phase IV Trials

After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.

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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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

In a clinical study, participants are often divided into groups.

In interventional studies, participants are prospectively assigned to arms and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.

In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.

Source

Clinical Trials.gov

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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. doi:10.1056/NEJMoa0802743. PMID 18539917. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.005. PMID 17599425. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.029. PMID 17599421. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.027. PMID 17599429. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.026. PMID 17599428. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.025. PMID 17599427. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.024. PMID 17599426. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.002. PMID 17599424. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.004. PMID 17599423. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.003. PMID 17599422. Unknown parameter |month= ignored (help)
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. doi:10.1016/j.amjcard.2007.03.028. PMID 17599420. Unknown parameter |month= ignored (help)

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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:

Not yet recruiting: participants are not yet being recruited or enrolled
Recruiting: participants are currently being recruited and enrolled
Enrolling by invitation: participants are being (or will be) selected from a predetermined population
Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Withdrawn: study halted prematurely, prior to enrollment of first participant

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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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Action To Control Cardiovascular Risk In Diabetes

Complete Title of Study

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

Principal Investigator, Co-investigators, and Collaborating Institutions

Overview of Trial

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

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

Phase I Trials

Phase II Trials

Phase III Trials

Phase IV Trials

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

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

Source

Primary Pre-Specified Endpoint

Secondary Endpoints

Inclusion Criteria

Exclusion Criteria

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

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

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

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

Conclusions of the Investigators (Quote the investigators conclusions here)

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

Slides

Video Commentary

References (How to insert a reference)

External sites for further information (How to insert links)

Detailed information about the trial

Ages

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

Accepts Healthy Volunteers (Answer yes or no)

Enrollment Period (Study start and end date)

Recruitment Status (explanation)

Enrollment (Total number of patients enrolled)

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

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

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