Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01754259 · ClinicalTrials.gov registry record · Phase 3
Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT01754259 is a Phase 3 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 47 participants.
The verdict
NCT01754259, a Phase 3 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 47 participants
- Enrollment target
Study Summary
Coronary vascular dysfunction is highly prevalent among patients with known or suspected Coronary Artery Disease (CAD)1, increases the severity of inducible myocardial ischemia (beyond the effects of upstream coronary obstruction)2, and identifies patients at high risk for serious adverse events, including cardiac death1, 3-5. Diabetic patients without known CAD with impaired coronary vascular function show a risk of cardiac death comparable to, and possibly higher, than that for non-diabetic patients with known CAD10. In the setting of increased oxygen demand, coronary vasodilator dysfunction can upset the supply-demand relationship and lead to myocardial ischemia, subclinical left ventricular dysfunction (diastolic and systolic), and symptoms. The significance of microvascular coronary dysfunction is increasingly recognized as invasive and non-invasive (PET) methods of quantifying CFR become available. Importantly, current treatment strategies for obstructive CAD, such as percutaneous coronary intervention with angioplasty and stenting, are not helpful in microvascular disease. Similarly, mortality-altering treatments for systolic heart failure, such as angiotensin converting enzyme inhibitors, have not been beneficial in treating diastolic dysfunction.
Interventions
- DRUG Placebo
- DRUG Ranolazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01754259
The ClinicalTrials.gov registry entry for NCT01754259 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01754259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01754259 about?
NCT01754259 is a clinical study titled "Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD". Coronary vascular dysfunction is highly prevalent among patients with known or suspected Coronary Artery Disease (CAD)1, increases the severity of inducible myocardial ischemia (beyond the effects of upstream coronary obstruction)2, and identifies patients at high risk for serious adverse events, in...
What is the current status of trial NCT01754259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2013-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01754259?
The interventions under investigation include: Placebo (DRUG), Ranolazine (DRUG).
Who is sponsoring clinical trial NCT01754259?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.