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

NCT01230892 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00027953Emory #00000681
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner lining of blood vessels to release a compound called nitric oxide that can relax blood vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric oxide and effect additional blood vessel relaxation. The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following parameters:

• Plaque within arteries supplying the heart in terms of its volume and composition as assessed by ultrasound within these arteries.
• Ability of small arteries in the heart to open up and deliver an enhanced blood supply in response to drug called Adenosine (routinely used in the cardiac catheterization laboratory) as assessed by pressure and flow detecting catheters within these arteries.
• Ability of the inner lining of arteries that supply the heart to release a relaxing compound called nitric oxide in response to injection of Acetylcholine (also used in the cardiac catheterization laboratory) as assessed by squirting dye into these arteries
• Local forces that affect blood flow in the arteries supplying the heart as assessed by superimposing the above data into complex maps created offline at Georgia Institute of Technology. It is likely that Nebivolol causes the plaque within arteries supplying the heart to change from the 'vulnerable' type to the 'stable' type plaque. There are several features of "vulnerable plaques" that can be detected in arteries of the heart using intravascular ultrasound (a small ultrasound camera that goes in the arteries of the heart). The investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing 'vulnerable plaques', improve blood flow within the small arteries and the health of inner lining of these arteries at the 1 year time point. The investigators plan to enroll 20 patients into the study (26 patient including dropouts) who will be randomized in a 1:1 manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.

Conditions

Atherosclerosis; Endothelial Function

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS

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

  1 year

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

Drug: Nebivolol

Atenolol

ACTIVE COMPARATOR

Drug: Atenolol

Interventions

Nebivolol DRUG

10 mg PO qday

Also known as: Bystolic

Nebivolol

Atenolol DRUG

100 mg PO qday

Also known as: Senormin, Tenormin

Atenolol

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable angina or acute coronary syndrome
• Moderate coronary lesion (defined as a lesion significant enough by the treating physician to warrant further evaluation using CFR or FFR or intravascular ultrasound assessment).
• Lesion located in the proximal 60mm of the RCA or LAD.
• On stable medical therapy for other cardiac risk factors.

You may not qualify if:

• Left Main lesion greater than 50% stenosis
• Patients with a history of coronary artery bypass surgery
• Severe valvular heart disease
• Patients presenting with a STEMI.
• Inability to provide informed consent prior to randomization
• Creatinine \>1.5
• Lesions located beyond 60mm in an epicardial vessel
• Coronary anatomy requiring CABG
• B-blocker, calcium channel blocker or extended-release nitrate therapy within last 48 hours.
• Bradycardia (HR\<50 bpm)
• Hypotension (SBP\<100mmHg)
• Severe COPD by pulmonary function testing

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Hung OY, Molony D, Corban MT, Rasoul-Arzrumly E, Maynard C, Eshtehardi P, Dhawan S, Timmins LH, Piccinelli M, Ahn SG, Gogas BD, McDaniel MC, Quyyumi AA, Giddens DP, Samady H. Comprehensive Assessment of Coronary Plaque Progression With Advanced Intravascular Imaging, Physiological Measures, and Wall Shear Stress: A Pilot Double-Blinded Randomized Controlled Clinical Trial of Nebivolol Versus Atenolol in Nonobstructive Coronary Artery Disease. J Am Heart Assoc. 2016 Jan 25;5(1):e002764. doi: 10.1161/JAHA.115.002764.

  PMID: 26811165 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Nebivolol; Atenolol

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols

Results Point of Contact

• Title: Dr. Habib Samady
• Organization: Emory University

hsamady@emory.edu

404-778-5299

Study Officials

• Habib Samady, MD, FACC

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: October 29, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02

Locations

US (1)