Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000620
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), National Institute on Aging (NIA) (NIH), National Eye Institute (NEI) (NIH), Centers for Disease Control and Prevention (U.S. Fed)
10,251
7
6
159
1464.4
9.2
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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 included the following: (1) Blood sugar - ACCORD was designed to determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk. The study estimated 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 was designed to determine the effects of lowering blood pressure in the context of good blood sugar control, that is to 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 were assigned to an intervention to improve blood fat levels. This part of the study looked 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" was used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" was used to lower LDL cholesterol.
All ACCORD participants received blood sugar treatment from the study. Based on the second trial (Blood Pressure or Lipid) they were assigned to, participants also received their high blood pressure or cholesterol care from the study. Study participants received all medication and treatments related to the study free of charge. Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care.
In summary, the ACCORD Study was a double 2x2 factorial design with factors consisting of:
intensive versus standard glycemic control, intensive versus standard blood pressure control, and blinded fenofibrate or placebo in combination with simvastatin to maintain desirable LDL-C levels. All 10,251 participants were randomized to the glycemic interventions; a subgroup of 4,733 participants who met the blood pressure entry criteria were randomized to the blood pressure interventions in one 2x2 trial; and a distinct subgroup of 5,518 participants who met the lipid entry criteria were randomized to the lipid interventions in the second 2x2 trial. All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites).
On February 6, 2008, the National Heart, Lung and Blood Institute (NHLBI) announced that participants in the intensive glycemia treatment would be transitioned to the ACCORD standard glycemic treatment approach due to higher mortality in the intensive treatment group terminating the experimental arm of the Glycemia Trial early. The Blood Pressure and Lipid trials continued as designed to their planned termination in 2009.
Study Design
Study Type:
Interventional
Actual Enrollment
:
10251 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Study Start Date
:
Sep 1, 1999
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Glycemia Trial: intensive control Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. |
Drug: Anti-hyperglycemic Agents
Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%).
Other Names:
|
| Active Comparator: Glycemia Trial: standard control Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 - 7.9%. |
Drug: Anti-hyperglycemic Agents
Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%).
Other Names:
|
| Experimental: BP Trial: intensive control Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. |
Drug: Anti-hypertensive Agents
Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).
Other Names:
|
| Active Comparator: BP Trial: standard control Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. |
Drug: Anti-hypertensive Agents
Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).
Other Names:
|
| Experimental: Lipid Trial: fenofibrate Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin. |
Drug: Blinded fenofibrate or placebo plus simvastatin
Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.
Other Names:
|
| Placebo Comparator: Lipid Trial: placebo Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin. |
Drug: Blinded fenofibrate or placebo plus simvastatin
Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. [4.9 years]
Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion.
- First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. [4.7 years]
Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.
- First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. [4.7 years]
Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.
Secondary Outcome Measures
- Death From Any Cause in the Glycemia Trial. [4.9 years]
Time to death from any cause. Secondary measure for Glycemia Trial. A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid).
- Stroke in the Blood Pressure Trial. [4.7 years]
Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.
- First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. [4.7 years]
Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minneapolis Medical Research Foundation | Minneapolis | Minnesota | United States | 55404 |
| 2 | Columbia University | New York | New York | United States | 10027 |
| 3 | Wake Forest University | Winston-Salem | North Carolina | United States | 27106 |
| 4 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 5 | Veterans Affairs | Memphis | Tennessee | United States | 38104 |
| 6 | University of Washington | Seattle | Washington | United States | 98195 |
| 7 | McMaster University | Hamilton | Ontario | Canada |
Sponsors and Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institute on Aging (NIA)
- National Eye Institute (NEI)
- Centers for Disease Control and Prevention
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- ACCORD Study Group, Buse JB, Bigger JT, Byington RP, Cooper LS, Cushman WC, Friedewald WT, Genuth S, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH Jr, Margolis KL, Probstfield JL, Simons-Morton DG, Sullivan MD. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol. 2007 Jun 18;99(12A):21i-33i. Epub 2007 Apr 16.
- Bonds DE, Kurashige EM, Bergenstal R, Brillon D, Domanski M, Felicetta JV, Fonseca VA, Hall K, Hramiak I, Miller ME, Osei K, Simons-Morton DG; ACCORD Study Group. Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):80i-89i. Epub 2007 Apr 17.
- Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. Epub 2007 Apr 13.
- Cushman WC, Grimm RH Jr, Cutler JA, Evans GW, Capes S, Corson MA, Sadler LS, Alderman MH, Peterson K, Bertoni A, Basile JN; ACCORD Study Group. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):44i-55i. Epub 2007 Apr 16.
- Gerstein HC, Riddle MC, Kendall DM, Cohen RM, Goland R, Feinglos MN, Kirk JK, Hamilton BP, Ismail-Beigi F, Feeney P; ACCORD Study Group. Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):34i-43i. Epub 2007 Apr 19.
- Ginsberg HN, Bonds DE, Lovato LC, Crouse JR, Elam MB, Linz PE, O'connor PJ, Leiter LA, Weiss D, Lipkin E, Fleg JL; ACCORD Study Group. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):56i-67i. Epub 2007 Apr 12.
- Goff DC Jr, Gerstein HC, Ginsberg HN, Cushman WC, Margolis KL, Byington RP, Buse JB, Genuth S, Probstfield JL, Simons-Morton DG; ACCORD Study Group. 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. 2007 Jun 18;99(12A):4i-20i. Epub 2007 Apr 12. Review.
- Kingry C, Bastien A, Booth G, Geraci TS, Kirpach BR, Lovato LC, Margolis KL, Rosenberg Y, Sperl-Hillen JM, Vargo L, Williamson JD, Probstfield JL; ACCORD Study Group. Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):68i-79i. Epub 2007 Apr 12.
- Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, Narayan KM, Nwachuku C, O'Connor PJ, Zhang P; ACCORD Study Group. 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. 2007 Jun 18;99(12A):90i-102i. Epub 2007 Apr 13.
- Williamson JD, Miller ME, Bryan RN, Lazar RM, Coker LH, Johnson J, Cukierman T, Horowitz KR, Murray A, Launer LJ; ACCORD Study Group. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. Epub 2007 Apr 12.
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
Other Study ID Numbers:
- 123
- N01HC95178
- N01HC95179
- N01HC95180
- N01HC95181
- N01HC95182
- N01HC95183
- N01HC95184
- IAA#Y1HC9035
- IAA#Y1HC1010
- NCT00182910
First Posted:
Oct 28, 1999
Last Update Posted:
Nov 22, 2016
Last Verified:
Nov 1, 2014
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites). Recruitment occurred in two phases, from January to June 2001 and from February 2003 to October 2005. |
|---|---|
| Pre-assignment Detail | Eligible participants provided evidence of ability to routinely monitor capillary blood sugars from written records or electronic downloads from a self-monitoring blood glucose device (SMBG), or (in cases where such records could not be provided) underwent a 2 to 4-week pre-randomization run-in period to evaluate compliance with SMBG monitoring. |
| Arm/Group Title | Glycemia Trial: Intensive Control/BP Trial: Intensive Control | Glycemia Trial: Intensive Control/BP Trial: Standard Control | Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate | Glycemia Trial: Intensive Control/Lipid Trial: Placebo | Glycemia Trial: Standard Control/BP Trial: Intensive Control | Glycemia Trial: Standard Control/BP Trial: Standard Control | Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate | Glycemia Trial: Standard Control/Lipid Trial: Placebo |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg). | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. | Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day. |
| Period Title: Overall Study | ||||||||
| STARTED | 1178 | 1193 | 1374 | 1383 | 1184 | 1178 | 1391 | 1370 |
| COMPLETED | 1016 | 1057 | 1204 | 1205 | 1049 | 1026 | 1242 | 1224 |
| NOT COMPLETED | 162 | 136 | 170 | 178 | 135 | 152 | 149 | 146 |
Baseline Characteristics
| Arm/Group Title | Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control | Total |
|---|---|---|---|
| Arm/Group Description | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | Total of all reporting groups |
| Overall Participants | 5128 | 5123 | 10251 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.2
(6.8)
|
62.2
(6.8)
|
62.2
(6.8)
|
| Gender (Count of Participants) | |||
| Female |
1983
38.7%
|
1969
38.4%
|
3952
38.6%
|
| Male |
3145
61.3%
|
3154
61.6%
|
6299
61.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
358
7%
|
379
7.4%
|
737
7.2%
|
| Not Hispanic or Latino |
4770
93%
|
4744
92.6%
|
9514
92.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Nonwhite |
1828
35.6%
|
1819
35.5%
|
3647
35.6%
|
| White |
3300
64.4%
|
3304
64.5%
|
6604
64.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
4376
85.3%
|
4367
85.2%
|
8743
85.3%
|
| Canada |
752
14.7%
|
756
14.8%
|
1508
14.7%
|
| Previous cardiovascular disease (CVD) event (participants) [Number] | |||
| History of CVD event |
1827
35.6%
|
1782
34.8%
|
3609
35.2%
|
| No history of CVD event |
3301
64.4%
|
3341
65.2%
|
6642
64.8%
|
| Glycated hemoglobin (percent) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percent] |
8.3
(1.1)
|
8.3
(1.1)
|
8.3
(1.1)
|
| Blood pressure (mm Hg) [Mean (Standard Deviation) ] | |||
| Systolic |
136.2
(17.0)
|
136.5
(17.2)
|
136.4
(17.1)
|
| Diastolic |
74.8
(10.6)
|
75.0
(10.7)
|
74.9
(10.7)
|
| Cholesterol (mg/dL) [Mean (Standard Deviation) ] | |||
| LDL |
104.9
(34.0)
|
104.9
(33.8)
|
104.9
(33.9)
|
| HDL |
41.8
(11.8)
|
41.9
(11.5)
|
41.9
(11.6)
|
| Triglycerides (mg/dL) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [mg/dL] |
156
|
154
|
155
|
| Diabetes duration (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
10
|
10
|
10
|
Outcome Measures
| Title | First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. |
|---|---|
| Description | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial). In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion. |
| Time Frame | 4.9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. |
| Arm/Group Title | Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control |
|---|---|---|
| Arm/Group Description | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. |
| Measure Participants | 5128 | 5123 |
| Number [participants] |
503
9.8%
|
543
10.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.12 |
| Comments | P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Death From Any Cause in the Glycemia Trial. |
|---|---|
| Description | Time to death from any cause. Secondary measure for Glycemia Trial. A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid). |
| Time Frame | 4.9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death. |
| Arm/Group Title | Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control |
|---|---|---|
| Arm/Group Description | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. |
| Measure Participants | 5128 | 5123 |
| Number [participants] |
391
7.6%
|
327
6.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.19 | |
| Confidence Interval |
(2-Sided) 95% 1.03 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. |
|---|---|
| Description | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. |
| Time Frame | 4.7 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. |
| Arm/Group Title | BP Trial: Intensive Control | BP Trial: Standard Control |
|---|---|---|
| Arm/Group Description | Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals. | Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals. |
| Measure Participants | 2363 | 2371 |
| Number [participants] |
208
4.1%
|
237
4.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | P-value is adjusted for interim monitoring. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.73 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Stroke in the Blood Pressure Trial. |
|---|---|
| Description | Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. |
| Time Frame | 4.7 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke. |
| Arm/Group Title | BP Trial: Intensive Control | BP Trial: Standard Control |
|---|---|---|
| Arm/Group Description | Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. | Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals. |
| Measure Participants | 2363 | 2371 |
| Number [participants] |
36
0.7%
|
62
1.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.01 |
| Comments | P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.59 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 0.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. |
|---|---|
| Description | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. |
| Time Frame | 4.7 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. |
| Arm/Group Title | Lipid Trial: Fenofibrate | Lipid Trial: Placebo |
|---|---|---|
| Arm/Group Description | Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day. | Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day. |
| Measure Participants | 2765 | 2753 |
| Number [participants] |
291
5.7%
|
310
6.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.32 |
| Comments | P-value is adjusted for interim monitoring. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.92 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial. |
|---|---|
| Description | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. |
| Time Frame | 4.7 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event. |
| Arm/Group Title | Lipid Trial: Fenofibrate | Lipid Trial: Placebo |
|---|---|---|
| Arm/Group Description | Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day. | Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day. |
| Measure Participants | 2765 | 2753 |
| Number [participants] |
641
12.5%
|
667
13%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Glycemia Trial: Intensive Control, Glycemia Trial: Standard Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05. | |
| Method | Regression, Cox | |
| Comments | Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.05 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Includes Serious Adverse Events (SAEs) reported after randomization and throughout the planned observation period, mean follow-up was 4.9 years. Data on other (non-serious) adverse events were not collected. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs were defined as any adverse experience that was significantly life threatening and/or resulted in death, permanent disability, hospitalization or prolongation of hospitalization, myositis/myopathy, or hepatitis and were considered by the investigators to be possibly, probably, or definitely related to study treatments. | |||
| Arm/Group Title | Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control | ||
| Arm/Group Description | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | ||
All Cause Mortality |
||||
| Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 137/5128 (2.7%) | 107/5123 (2.1%) | ||
| Cardiac disorders | ||||
| Congestive heart failure | 34/5128 (0.7%) | 12/5123 (0.2%) | ||
| Bradycardia, tachycardia, atrial fibrillation | 13/5128 (0.3%) | 4/5123 (0.1%) | ||
| Angina/chest pain | 4/5128 (0.1%) | 5/5123 (0.1%) | ||
| Myocardial infarction | 4/5128 (0.1%) | 5/5123 (0.1%) | ||
| Endocrine disorders | ||||
| Pancreatitis | 5/5128 (0.1%) | 8/5123 (0.2%) | ||
| Ketoacidosis | 1/5128 (0%) | 0/5123 (0%) | ||
| Hypoglycemia (fatal) | 0/5128 (0%) | 1/5123 (0%) | ||
| Eye disorders | ||||
| Macular edema | 1/5128 (0%) | 1/5123 (0%) | ||
| Blurred vision | 1/5128 (0%) | 1/5123 (0%) | ||
| Gastrointestinal disorders | ||||
| Cholecystitis | 5/5128 (0.1%) | 11/5123 (0.2%) | ||
| Hepatitis/liver failure | 2/5128 (0%) | 3/5123 (0.1%) | ||
| Elevated creatinine, hyponatremia | 2/5128 (0%) | 1/5123 (0%) | ||
| Gastrointestinal bleeding | 1/5128 (0%) | 1/5123 (0%) | ||
| General disorders | ||||
| Hyperkalemia | 6/5128 (0.1%) | 5/5123 (0.1%) | ||
| Hyponatremia | 0/5128 (0%) | 4/5123 (0.1%) | ||
| Severe fluid retention | 3/5128 (0.1%) | 1/5123 (0%) | ||
| Dehydration | 1/5128 (0%) | 2/5123 (0%) | ||
| Vertigo | 0/5128 (0%) | 1/5123 (0%) | ||
| Anemia | 0/5128 (0%) | 1/5123 (0%) | ||
| Hypomagnesemia | 0/5128 (0%) | 1/5123 (0%) | ||
| Hyperosmolar nonketotic coma | 1/5128 (0%) | 0/5123 (0%) | ||
| Toxic metabolic enecphalopathy | 1/5128 (0%) | 0/5123 (0%) | ||
| Immune system disorders | ||||
| Angioedema | 9/5128 (0.2%) | 4/5123 (0.1%) | ||
| Thrombocytopenia | 2/5128 (0%) | 0/5123 (0%) | ||
| Blood dyscrasia | 1/5128 (0%) | 0/5123 (0%) | ||
| Felodipine toxicity | 1/5128 (0%) | 0/5123 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Motor vehicle accident (fatal) | 3/5128 (0.1%) | 2/5123 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myositis | 2/5128 (0%) | 3/5123 (0.1%) | ||
| Rhabdomyolisis | 1/5128 (0%) | 2/5123 (0%) | ||
| Fractures | 1/5128 (0%) | 2/5123 (0%) | ||
| Weakness | 0/5128 (0%) | 1/5123 (0%) | ||
| Renal and urinary disorders | ||||
| Acute or chronic renal failure | 8/5128 (0.2%) | 6/5123 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Shortness of breath | 1/5128 (0%) | 0/5123 (0%) | ||
| Vascular disorders | ||||
| Dizziness, hypotension, syncope | 19/5128 (0.4%) | 17/5123 (0.3%) | ||
| Edema | 3/5128 (0.1%) | 1/5123 (0%) | ||
| Cerebrovacular accident | 1/5128 (0%) | 1/5123 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Glycemia Trial: Intensive Control | Glycemia Trial: Standard Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Tim Craven / Senior Biostatistician |
|---|---|
| Organization | Wake Forest School of Medicine |
| Phone | 336-716-6109 |
| tcraven@wakehealth.edu |
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
Other Study ID Numbers:
- 123
- N01HC95178
- N01HC95179
- N01HC95180
- N01HC95181
- N01HC95182
- N01HC95183
- N01HC95184
- IAA#Y1HC9035
- IAA#Y1HC1010
- NCT00182910
First Posted:
Oct 28, 1999
Last Update Posted:
Nov 22, 2016
Last Verified:
Nov 1, 2014