Trial Outcomes & Findings for Evaluation of Atorvastatin on Atherosclerosis Composition (NCT NCT00576576)

NCT ID: NCT00576576

Last Updated: 2013-12-24

Results Overview

Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2013-12-24

Participant Flow

27 subjects enrolled and followed up for 6 months All subjects were recruited between 2007 and 2009 at Emory University Hospital

Participant milestones

Measure	Atorvastatin All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Overall Study STARTED	27
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Atorvastatin All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of Atorvastatin on Atherosclerosis Composition

Baseline characteristics by cohort

Measure	Atorvastatin n=20 Participants All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	54 years INTER_QUARTILE_RANGE 46-68 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled patients with complete data set

Virtual Histology-Intravascular Ultrasound (VH-IVUS) defined necrotic core cross sectional area (CSA) measured in each VH-IVUS frame and averaged over length of studied vessel at baseline and follow -up. Change in necrotic core CSA between baseline and follow-up was calculated (subtracting the baseline value from the follow-up value).

Outcome measures

Measure	Atorvastatin n=20 Participants All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Change in Necrotic Core Volume	0.07 mm^2 Standard Deviation 0.06

SECONDARY outcome

Timeframe: 6 months

Population: All enrolled patients with complete data set

Change in atheroma volume between baseline and follow-up is reported. This was derived by subtracting the baseline value from the 6-month value.

Outcome measures

Measure	Atorvastatin n=20 Participants All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Change in Atheroma Volume	-4.0 mm^3 Interval -20.4 to 11.6

SECONDARY outcome

Timeframe: 6 months

Population: All enrolled patients with complete data set

Change in fibrous plaque volume between baseline and follow-up. This was derived by subtracting the baseline value from the 6-month value.

Outcome measures

Measure	Atorvastatin n=20 Participants All patients in this arm are given atorvastatin therapy. Atorvastatin : Atorvastatin 80 mg a day
Change in Fibrous Plaque Volume	-3.3 mm^3 Interval -15.2 to 8.3

Adverse Events

Atorvastatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Habib Samady

Emory

Phone: 4047781237

Email: hsamady@emory.edu

Results disclosure agreements

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