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Cardiovascular DiseasePhase 4SANDSNCT00147251

Stop Atherosclerosis in Native Diabetics Study

A Phase 4 study testing FDA approved drugs to treat blood pressure and cholesterol in people with Cardiovascular Disease and Hypertension, run by Cynthia West at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
What is being tested?
FDA approved drugs to treat blood pressure and cholesterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
548 participants
Where
4 sitesUnited States
Study dates
May 2003to 1 May 2007
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • American Indian men and women 40 years of age or older
  • 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.
  • LDL cholesterol >= 100 mg/dL. within the previous 12 months.
  • Systolic BP >= 130 mm Hg. within the previous 12 months.

Who cannot join

  • New York Heart Association Stage III- IV congestive heart failure.
  • SBP >180 mmHg (2% of population) or patients with known causes of hypertension.
  • History of angioedema.
  • Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
  • Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
  • Serum hepatic transaminase levels 2X the upper limit of normal.
Show all 19Show fewer
  • Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
  • Renal insufficiency as indicated by serum creatinine >2.0 for women and >2.4 for men.
  • Diagnosis of primary hyperlipidemia in medical record.
  • Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
  • Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
  • 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.
  • Unable to obtain quantifiable carotid measure during screening examination.
  • 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).
  • Orthostatic hypotension as defined by the following:
  • 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)
  • The standing systolic blood pressure is less than 90 mm.
  • Triglyceride level >350 mg/dl.
  • Severe aortic stenosis with valve area <=1.0 square cm.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Chinle Comprehensive Health Care

    Chinle, Arizona, 86503

  • USPHS Indian Hospital

    Lawton, Oklahoma, 73507

  • Phoenix Indian Medical Center

    Phoenix, Arizona, 85016

  • Black Hills Center for American Indian Health

    Rapid City, South Dakota, 57701

Other trials in United States

About this study

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.

Read the 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.

Being tested
FDA approved drugs to treat blood pressure and cholesterol
Keywords
lowering LDL and BP below current targets, LDL cholesterol treatment, blood pressure treatment, carotid intimal medial thickness, prevent progression of CVD
Medical subject headings
Cardiovascular Diseases, Hypertension, Hyperlipidemias, Diabetes Mellitus, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDA approved drugs to treat blood pressure and cholesterolDrug

    Also called No Intervention

Study groups in NCT00147251
Study groupRoleWhat they receive
SANDS Control GroupNo interventionStandard Treatment for blood pressure and cholesterol
SANDS Intervention GroupActive comparatorFDA approved drugs to treat blood pressure and cholesterol
Receives: Drug: FDA approved drugs to treat blood pressure and cholesterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changing LDL Cholesterol

    LDL cholesterol intervention to lower targets than are currently recommended to retard atherosclerosis measured by LDL-C mg/dL.

    Scale: LDL cholesterol levels should be less than 100 mg/dL

    Measured: 36 months

Secondary outcomes (1)

  1. Changing Blood Pressure

    Treatment of blood pressure to prevent/reduce diseases of heart and blood vessels. Measured by mmHG.

    Normal values should be below 120/80 mm Hg.

    Measured: 36 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startMay 2003
  3. Primary completionNov 2006
  4. Study completion1 May 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147251
Sponsor's protocol ID
2000-285
Other IDs
Grant # 1 U01 HL67031
Acronym
SANDS
Status last verified
Jun 2021
First submitted
2 Sep 2005
Last updated
7 Jul 2021
Data monitoring committee
Yes

Publications

  • Roman MJ, Howard BV, Howard WJ, Mete M, Fleg JL, Lee ET, Devereux RB. Differential impacts of blood pressure and lipid lowering on regression of ventricular and arterial mass: the Stop Atherosclerosis in Native Diabetics Trial. Hypertension. 2011 Sep;58(3):367-71. doi: 10.1161/HYPERTENSIONAHA.111.172486. Epub 2011 Jul 25.

    PubMed 21788602

  • Fleg JL, Mete M, Howard BV, Umans JG, Roman MJ, Ratner RE, Silverman A, Galloway JM, Henderson JA, Weir MR, Wilson C, Stylianou M, Howard WJ. Effect of statins alone versus statins plus ezetimibe on carotid atherosclerosis in type 2 diabetes: the SANDS (Stop Atherosclerosis in Native Diabetics Study) trial. J Am Coll Cardiol. 2008 Dec 16;52(25):2198-205. doi: 10.1016/j.jacc.2008.10.031.

    PubMed 19095139

  • Howard BV, Roman MJ, Devereux RB, Fleg JL, Galloway JM, Henderson JA, Howard WJ, Lee ET, Mete M, Poolaw B, Ratner RE, Russell M, Silverman A, Stylianou M, Umans JG, Wang W, Weir MR, Weissman NJ, Wilson C, Yeh F, Zhu J. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA. 2008 Apr 9;299(14):1678-89. doi: 10.1001/jama.299.14.1678.

    PubMed 18398080

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FDA approved drugs to treat blood pressure and cholesterol in people with Cardiovascular Disease and Hypertension, run by Cynthia West at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing LDL Cholesterol (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147251, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.

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