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Trial record 15 of 116 for:    Atenolol

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

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ClinicalTrials.gov Identifier: NCT01230892
Recruitment Status : Completed
First Posted : October 29, 2010
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
Georgia Institute of Technology
Information provided by (Responsible Party):
Habib Samady, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Atherosclerosis
Endothelial Function
Interventions Drug: Nebivolol
Drug: Atenolol
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nebivolol Atenolol
Hide Arm/Group Description Nebivolol: 10 mg PO qday Atenolol: 100 mg PO qday
Period Title: Overall Study
Started 15 14
Completed 12 13
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             2             0
Arm/Group Title Nebivolol Atenolol Total
Hide Arm/Group Description Nebivolol: 10 mg PO qday Atenolol: 100 mg PO qday Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
55  (10) 50  (11) 52  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
8
  66.7%
7
  58.3%
15
  62.5%
Male
4
  33.3%
5
  41.7%
9
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  33.3%
2
  16.7%
6
  25.0%
White
8
  66.7%
10
  83.3%
18
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS
Hide Description Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nebivolol Atenolol
Hide Arm/Group Description:
Nebivolol: 10 mg PO qday
Atenolol: 100 mg PO qday
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: participants
4 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nebivolol Atenolol
Hide Arm/Group Description Nebivolol: 10 mg PO qday Atenolol: 100 mg PO qday
All-Cause Mortality
Nebivolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nebivolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nebivolol Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Habib Samady
Organization: Emory University
Phone: 404-778-5299
EMail: hsamady@emory.edu
Layout table for additonal information
Responsible Party: Habib Samady, Emory University
ClinicalTrials.gov Identifier: NCT01230892     History of Changes
Other Study ID Numbers: IRB00027953
Emory #00000681 ( Other Identifier: Other )
First Submitted: September 10, 2010
First Posted: October 29, 2010
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015