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NCT01230892 · ClinicalTrials.gov registry record · Phase 4
Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT01230892 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 29 participants.
The verdict
NCT01230892, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study 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 Atenol
Interventions
- DRUG Atenolol
- DRUG Nebivolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-02 |
| Est. Completion | 2013-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01230892
The ClinicalTrials.gov registry entry for NCT01230892 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atenolol is the first listed.
NCT01230892 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01230892 about?
NCT01230892 is a clinical study titled "Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques". 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...
What is the current status of trial NCT01230892?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2010-02. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01230892?
The interventions under investigation include: Atenolol (DRUG), Nebivolol (DRUG).
Who is sponsoring clinical trial NCT01230892?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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