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Trial NCT00000620

Resource URI: http://static.linkedct.org/resource/trials/NCT00000620
linkedct:acronym ACCORD
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13137>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/23778>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/27049>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/28479>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/28989>
linkedct:brief_title Action to Control Cardiovascular Risk in Diabetes (ACCORD)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1245>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5417>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5455>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5476>
linkedct:condition <http://static.linkedct.org/resource/condition/1288>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/3802>
linkedct:condition <http://static.linkedct.org/resource/condition/3823>
linkedct:condition <http://static.linkedct.org/resource/condition/6173>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct: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)
linkedct:description BACKGROUND: Currently, about 17 million Americans have been diagnosed with diabetes and more than 90 percent of them have type 2 diabetes. The number of people with this form of diabetes, formerly known as adult onset or non-insulin dependent diabetes, is growing rapidly. By 2050, the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million, of whom 27 million will have the type 2 form. Cardiovascular disease (CVD) is the leading cause of death in people with type 2 diabetes; these individuals die of CVD at rates two to four times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes. Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes. Women with a history of diabetes during pregnancy, adults with impaired glucose tolerance, people with a sedentary lifestyle, and members of a minority race/ethnicity are also at a greater risk for developing type 2 diabetes. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes. DESIGN NARRATIVE: The three strategies tested in ACCORD will include the following: (1) Blood sugar - ACCORD will determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk. The study will determine effects on CVD of that level compared with a level that is usually targeted. (2) Blood pressure - Many people with type 2 diabetes have high blood pressure. The blood pressure part of the trial will determine the effects of lowering blood pressure in the context of good blood sugar control. ACCORD will determine whether lowering blood pressure to normal (systolic pressure less than 120 mm Hg) will better reduce CVD risk, as compared to a usually-targeted level in current clinical practice (i.e., below the definition of hypertension; systolic pressure less than 140 mm Hg). (3) Blood Fats - Many people with diabetes have high levels of LDL ("bad") cholesterol and triglycerides, as well as low levels of HDL ("good") cholesterol. ACCORD participants who are selected for this part of the trial will be assigned to an intervention that improves blood fat levels. This part of the study will look at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol, all in the context of good blood sugar control. A drug from a class of drugs called "fibrates" will be used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" will be used to lower LDL cholesterol. All ACCORD participants will receive their blood sugar treatment from the study. Based on whatever else they are assigned to, participants will also receive their cholesterol or high blood pressure care from the study. Study participants will receive all medication and treatments related to the study free of charge. Individuals who are selected and consent to participate in the ACCORD study will continue to see their personal physician for all other health care. The ACCORD clinical trial enrolled 10,251 adults with type 2 diabetes in 77 clinics around the United States and Canada. All eligible participants will be in the blood sugar control part of the trial. Participants were randomly assigned to a treatment regimen involving either aggressive control or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they were assigned to either the high blood pressure or high blood fats (cholesterol and triglycerides) part of the study. On February 6, 2008, the NHLBI announced that participants in the intensive glycemia treatment will be transitioned to the ACCORD standard treatment approach due to higher mortality in the intensive treatment group. The blood pressure and lipid trials are continuing as designed.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 79 Years
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date June 2010
linkedct:enrollment 10251 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:has_dmc Yes
linkedct:id NCT00000620
linkedct:intervention <http://static.linkedct.org/resource/intervention/30474>
linkedct:intervention <http://static.linkedct.org/resource/intervention/30475>
linkedct:intervention <http://static.linkedct.org/resource/intervention/30476>
linkedct:intervention <http://static.linkedct.org/resource/intervention/33001>
linkedct:intervention <http://static.linkedct.org/resource/intervention/43232>
rdfs:label Trial NCT00000620
linkedct:lastchanged_date December 4, 2009
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:location <http://static.linkedct.org/resource/location/15113>
linkedct:location <http://static.linkedct.org/resource/location/153689>
linkedct:location <http://static.linkedct.org/resource/location/165929>
linkedct:location <http://static.linkedct.org/resource/location/179846>
linkedct:location <http://static.linkedct.org/resource/location/182405>
linkedct:location <http://static.linkedct.org/resource/location/189817>
linkedct:location <http://static.linkedct.org/resource/location/220436>
linkedct:nct_id NCT00000620
linkedct:number_of_arms 5 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Action to Control Cardiovascular Risk in Diabetes (ACCORD)
linkedct:org_study_id 123
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/13546>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/50375>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/61383>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000620>
linkedct:phase Phase 3
linkedct:primary_completion_date June 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/45825>
linkedct:reference <http://static.linkedct.org/resource/reference/34425>
linkedct:reference <http://static.linkedct.org/resource/reference/34426>
linkedct:reference <http://static.linkedct.org/resource/reference/34427>
linkedct:reference <http://static.linkedct.org/resource/reference/34428>
linkedct:reference <http://static.linkedct.org/resource/reference/34429>
linkedct:reference <http://static.linkedct.org/resource/reference/34430>
linkedct:reference <http://static.linkedct.org/resource/reference/34431>
linkedct:reference <http://static.linkedct.org/resource/reference/34432>
linkedct:reference <http://static.linkedct.org/resource/reference/34433>
linkedct:reference <http://static.linkedct.org/resource/reference/34434>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/8434>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/110586>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1999
linkedct:study_design Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2009