At a glance
ClinicalIndex Comparison Record- ✓American Indian men and women 40 years or older
- ✓Type 2 diabetes mellitus per ADA/WHO criteria (fasting glucose ≥126 mg/dL or 2-hour glucose ≥200 mg/dL)
- ✓LDL cholesterol ≥100 mg/dL within past 12 months
- ✓Systolic BP ≥130 mmHg within past 12 months
- ✕NYHA Stage III–IV congestive heart failure
- ✕Systolic BP >180 mmHg
- ✕History of angioedema
- ✕Serum hepatic transaminase levels ≥2× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stop Atherosclerosis in Native Diabetics Study
In Brief
A Phase 4 clinical trial evaluating FDA approved drugs to treat blood pressure and cholesterol for Cardiovascular Disease and 4 related conditions. Completed, enrolled 548 participants across 4 sites.
Detailed 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.