Trial Outcomes & Findings for Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques (NCT NCT01230892)

NCT ID: NCT01230892

Last Updated: 2015-02-27

Results Overview

Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2015-02-27

Participant Flow

Participant milestones

Measure	Nebivolol Nebivolol: 10 mg PO qday	Atenolol Atenolol: 100 mg PO qday
Overall Study STARTED	15	14
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Nebivolol Nebivolol: 10 mg PO qday	Atenolol Atenolol: 100 mg PO qday
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques

Baseline characteristics by cohort

Measure	Nebivolol n=12 Participants Nebivolol: 10 mg PO qday	Atenolol n=12 Participants Atenolol: 100 mg PO qday	Total n=24 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 10 • n=5 Participants	50 years STANDARD_DEVIATION 11 • n=7 Participants	52 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 4 subjects either withdrew or were lost to follow-up and not included in analysis population. Additionally, one subject in the Atenolol arm was removed from analysis population due to IVUS occurring in the incorrect artery and one subject in the Nebivolol arm was removed due to the IVUS catheter malfunctioning.

Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)

Outcome measures

Measure	Nebivolol n=11 Participants Nebivolol: 10 mg PO qday	Atenolol n=12 Participants Atenolol: 100 mg PO qday
Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS	4 participants	6 participants

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atenolol

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 University

Phone: 404-778-5299

Email: hsamady@emory.edu

Results disclosure agreements

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