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Stop Atherosclerosis in Native Diabetics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147251
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : November 1, 2006
Sponsor:
Information provided by:
Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date November 1, 2006
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
combined carotid artery intimal medial thickness measured at 3 years and clinical CVD events tracked throughout the 3 years
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
1. combined carotid artery intimal medial thickness measured at 3 years and clinical CVD events tracked throughout the 3 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • left ventricular (LV) function and geometry
  • level of stenosis of the carotid artery
  • number of plaques in the carotid artery
  • various safety measures, such as liver enzyme levels, clinical myositis, postural hypotension, glomerular filtration rate, urine albumin/creatinine ratio
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • 1.left ventricular (LV) function and geometry
  • 2.level of stenosis of the carotid artery
  • 3.number of plaques in the carotid artery
  • 4.various safety measures, such as liver enzyme levels, clinical myositis, postural hypotension, glomerular filtration rate, urine albumin/creatinine ratio
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stop Atherosclerosis in Native Diabetics Study
Official Title  ICMJE Stop Atherosclerosis in Native Diabetics Study
Brief Summary Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a randomized 3-year trial. The primary endpoint will be a combination of various measures of the carotid artery, (which is an easy, non-invasive way to detect cardiovascular disease) and events such as heart attacks and strokes. The study will also look at secondary endpoints such as how well the heart pumps, fat,protein and inflammatory markers in the blood,and kidney function. The study enrolled 549 American Indian men and women with diabetes, > 40 years of age and is being conducted in four field centers involving Indian Health Service/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members.
Detailed Description Diabetes incidence is increasing rapidly in the United States. Diabetes increases the risk for CVD, the major cause of death in diabetic individuals. The conventional cardiovascular risk factors of hyperlipidemia and hypertension add to the progression of diabetic vascular disease. Appropriate treatment targets for LDL-C and blood pressure in diabetic individuals are currently being debated. The Stop Atherosclerosis in Native Diabetics Study is a randomized, open label, 3-year, clinical trial to examine the effects of aggressive LDL-C (goal < 70 mg/dL) and BP (goal < 115/75 mm Hg) reduction versus the standard goals of < 100 mg/dL for LDL-C and < 130/85 mmHg for BP. Five hundred forty-nine American Indian men and women > age 40 with type 2 diabetes were randomized to one of two groups. Lipids and BP are managed using FDA-approved medications in an algorithmic approach. The presence and progression of atherosclerosis are evaluated by carotid ultrasonography; echocardiography assesses cardiac function. The primary endpoint is the composite outcome of change in carotid artery intimal medial thickness and fatal/nonfatal cardiovascular events. These outcomes are combined by using a ranked analysis for carotid thickness and assigning a "worst rank" for a cardiovascular event. Secondary endpoints include carotid plaque score, left ventricular geometry and function, serum CRP, and safety measures. Unique aspects of the study design and analysis plan involve changes during the trial of LDL-C treatment goals for participants with baseline or incident CVD in the conventional group, because of changes in the standard of care, and the use of a composite outcome. Study results will be valuable in understanding the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all U.S. populations and will provide evidence for determining optimal LDL-C and BP treatment goals for diabetic patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Carotid Atherosclerosis
Intervention  ICMJE Drug: FDA approved drugs to treat blood pressure and cholesterol
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 2, 2005)
548
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. American Indian men and women 40 years of age or older
  2. Type 2 DM (according to 1997 ADA criteria and/or previously diagnosed by former ADA or WHO criteria): fasting plasma glucose >= 7.0 mmol/L (126 mg/dL) or 2-hour glucose >= 11.0 mmol/L (>200 mg/dL) after a 75-gram oral glucose tolerance test.
  3. LDL cholesterol >= 100 mg/dL. within the previous 12 months.
  4. Systolic BP >= 130 mm Hg. within the previous 12 months.

Exclusion Criteria:

  1. New York Heart Association Stage III- IV congestive heart failure.
  2. SBP >180 mmHg (2% of population) or patients with known causes of hypertension.
  3. History of angioedema.
  4. Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
  5. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
  6. Serum hepatic transaminase levels  2X the upper limit of normal.
  7. Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
  8. Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men.
  9. Diagnosis of primary hyperlipidemia in medical record.
  10. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
  11. Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
  12. Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy.
  13. Unable to obtain quantifiable carotid measure during screening examination.
  14. Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept).
  15. Orthostatic hypotension as defined by the following:

    1. The individual has a measured fall of >20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP)
    2. The standing systolic blood pressure is less than 90 mm.
  16. Triglyceride level >350 mg/dl.
  17. Severe aortic stenosis with valve area <=1.0 square cm.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147251
Other Study ID Numbers  ICMJE 2000-285
Grant # 1 U01 HL67031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara V Howard, PhD Medstar Health Research Institute
PRS Account Medstar Health Research Institute
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP