Trial Outcomes & Findings for Effect of Valsartan on Carotid Artery Disease (NCT NCT00208767)

NCT ID: NCT00208767

Last Updated: 2015-12-08

Results Overview

The PI will measure carotid artery thickening with magnetic resonance imaging.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 120 participants
• Primary outcome timeframe: Baseline, 2 years
• Results posted on: 2015-12-08

Participant Flow

Emory Healthcare sites or by advertisement between March 2005 and October 2008.

60 of the enrolled subjects were already on long-term statin therapy and were stratified for statin use before randomization. Subjects on statin therapy were switched to simvastatin 40 mg daily unless they were already on high dose statin therapy and thus were placed on 80 mg daily of simvastatin for the duration of the study.

Participant milestones

Measure	Valsartan Valsartan titrated up to 320 mg orally daily Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily	Placebo Patients received a placebo instead of Valsartan
Overall Study STARTED	80	40
Overall Study COMPLETED	53	33
Overall Study NOT COMPLETED	27	7

Reasons for withdrawal

Measure	Valsartan Valsartan titrated up to 320 mg orally daily Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily	Placebo Patients received a placebo instead of Valsartan
Overall Study Adverse Event	9	1
Overall Study Withdrawal by Subject	14	3
Overall Study Death	1	0
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Effect of Valsartan on Carotid Artery Disease

Baseline characteristics by cohort

Measure	Valsartan n=80 Participants Valsartan titrated up to 320 mg orally daily Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily	Placebo n=40 Participants Patients received a placebo instead of Valsartan	Total n=120 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 9 • n=5 Participants	62 years STANDARD_DEVIATION 9 • n=7 Participants	60 years STANDARD_DEVIATION 9 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	40 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	21 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	19 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants	40 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 years

The PI will measure carotid artery thickening with magnetic resonance imaging.

Outcome measures

Measure	Valsartan n=49 Participants Valsartan titrated up to 320 mg orally daily Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily	Placebo n=27 Participants Patients received a placebo instead of Valsartan
Change in the Mean Vessel Wall Area (VMA) of the Carotid Bulb From Baseline to 2 Years	-6.7 mm2 Standard Deviation 2.4	3.4 mm2 Standard Deviation 3.1

Adverse Events

Valsartan

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valsartan n=80 participants at risk Valsartan titrated up to 320 mg orally daily Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily	Placebo n=40 participants at risk Patients received a placebo instead of Valsartan
Respiratory, thoracic and mediastinal disorders Death	1.2% 1/80 • Number of events 1	0.00% 0/40
Cardiac disorders Stroke	1.2% 1/80 • Number of events 1	0.00% 0/40
Injury, poisoning and procedural complications Majory injury/accident	1.2% 1/80 • Number of events 1	0.00% 0/40

Other adverse events

Adverse event data not reported

Additional Information

Dr. Arshed Quyyumi

Emory University School of Medicine

Phone: 404-727-3655

Email: aquyyum@emory.edu

Results disclosure agreements

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