A Phase 4 interventional study of FDA approved drugs to treat blood pressure and cholesterol in Cardiovascular Disease, Hypertension and Hyperlipidemia, sponsored by Cynthia West. Completed at 4 sites in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Cynthia West · Phase 4, Interventional, and Prevention
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.
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.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's enrollment of 548 is above the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →This is the only study on the registry with Cynthia West as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Orthostatic hypotension as defined by the following:
Standard Treatment for blood pressure and cholesterol
FDA approved drugs to treat blood pressure and cholesterol
Drug: FDA approved drugs to treat blood pressure and cholesterol
Also known as: No Intervention
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
Time frame: 36 months
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.
Time frame: 36 month follow-up
Participants were identified from the local Indian hospital service center, or DM clinic. In March 2004, the DSMB recommended and the SC voted to over-recruit by 10-20% to compensate for the possible need for more aggressive treatment for participants with baseline CVD. Randomization concluded in July 2004 with 547 randomized participants.
| Milestone | Standard Treatment | Aggressive Treatment |
|---|---|---|
| Started | 271 | 277 |
| Completed | 247 | 252 |
| Not completed | 24 | 25 |
| Withdrew: Change in treatment guidelines | 24 | 25 |
| Milestone | Standard Treatment | Aggressive Treatment |
|---|---|---|
| Started | 247 | 252 |
| Completed | 247 | 252 |
| Not completed | 0 | 0 |
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
| Mg/dl | Standard Treatment | Aggressive Treatment |
|---|---|---|
| Changing LDL Cholesterol | 100 ± 74 | 70 ± 91 |
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.
| mm Hg | SANDS Control Group | SANDS Intervention Group |
|---|---|---|
| Changing Blood Pressure | 130 ± .001 | 115 ± .001 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SANDS Control Group | — | 1/247 (0.4%) | 0/247 (0%) |
| SANDS Intervention Group | — | 4/252 (1.6%) | 0/252 (0%) |
| Event | SANDS Control Group | SANDS Intervention Group |
|---|---|---|
| Heart AttackVascular disorders | 1/247 | 4/252 |
| Age, Continuous(years) | Standard Treatment | Aggressive Treatment | Total |
|---|---|---|---|
| Mean | 56.9 ± 4.24 | 55.3 ± 4.24 | 56.1 ± 4.24 |
| Sex: Female, Male(Participants) | Standard Treatment | Aggressive Treatment | Total |
|---|---|---|---|
| Female | 163 | 164 | 327 |
| Male | 84 | 88 | 172 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.