Trial Outcomes & Findings for Stop Atherosclerosis in Native Diabetics Study (NCT NCT00147251)

NCT ID: NCT00147251

Last Updated: 2021-07-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 548 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2021-07-07

Participant Flow

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.

Sonogram eligibility was confirmed by tape review at the core lab prior to randomization. A potential participant had to have LDL-C > 100 mg/dL and systolic BP > 130/85 mmHg. A participant could undergo a maximum of four screening visits within a 3-month period to confirm eligibility.

Participant milestones

Measure	Standard Treatment standard targets of LDL-C \< 100 mg/dL and BP \< 130/85 mm Hg	Aggressive Treatment /aggressive targets of LDL-C \< 70 mg/dL plus BP \< 115/75 mm Hg
Recruitment and Enrollment STARTED	271	277
Recruitment and Enrollment COMPLETED	247	252
Recruitment and Enrollment NOT COMPLETED	24	25
Follow up STARTED	247	252
Follow up COMPLETED	247	252
Follow up NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Standard Treatment standard targets of LDL-C \< 100 mg/dL and BP \< 130/85 mm Hg	Aggressive Treatment /aggressive targets of LDL-C \< 70 mg/dL plus BP \< 115/75 mm Hg
Recruitment and Enrollment change in treatment guidelines	24	25

Baseline Characteristics

Stop Atherosclerosis in Native Diabetics Study

Baseline characteristics by cohort

Measure	Standard Treatment n=247 Participants standard targets of LDL-C \< 100 mg/dL and BP \< 130/85 mm Hg	Aggressive Treatment n=252 Participants /aggressive targets of LDL-C \< 70 mg/dL plus BP \< 115/75 mm Hg	Total n=499 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 4.24 • n=5 Participants	55.3 years STANDARD_DEVIATION 4.24 • n=7 Participants	56.1 years STANDARD_DEVIATION 4.24 • n=5 Participants
Sex: Female, Male Female	163 Participants n=5 Participants	164 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	88 Participants n=7 Participants	172 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Native American

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

Outcome measures

Measure	Standard Treatment n=247 Participants standard targets of LDL-C \< 100 mg/dL and	Aggressive Treatment n=252 Participants /aggressive targets of LDL-C \< 70 mg/dL
Changing LDL Cholesterol	100 Mg/dl Standard Deviation 74	70 Mg/dl Standard Deviation 91

SECONDARY outcome

Timeframe: 36 month follow-up

Population: American Indian

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.

Outcome measures

Measure	Standard Treatment n=247 Participants standard targets of LDL-C \< 100 mg/dL and	Aggressive Treatment n=252 Participants /aggressive targets of LDL-C \< 70 mg/dL
Changing Blood Pressure	130 mm Hg Standard Deviation .001	115 mm Hg Standard Deviation .001

Adverse Events

SANDS Control Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

SANDS Intervention Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	SANDS Control Group n=247 participants at risk Standard Treatment for blood pressure and cholesterol	SANDS Intervention Group n=252 participants at risk FDA approved drugs to treat blood pressure and cholesterol
Vascular disorders Heart Attack	0.40% 1/247 • Number of events 1 • 3 years	1.6% 4/252 • Number of events 4 • 3 years

Other adverse events

Adverse event data not reported

Additional Information

Barbara V Howard

MedStar Research Institute

Phone: 301-560-7305

Email: barbara.v.howard@medstar.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place