| Trial ID: | L5501 |
| Source ID: | NCT01754259
|
| Associated Drug: |
Ranolazine
|
| Title: |
Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
|
| Acronym: |
RAND-CFR
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01754259/results
|
| Conditions: |
Diabetes, Type I|Diabetes, Type II|Angina|Coronary Artery Disease
|
| Interventions: |
DRUG: Ranolazine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Post-exercise Coronary Vasodilator Reserve, Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order., 4 weeks | Secondary: Change in LV Diastolic Function, Change (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E') at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e'), septal and lateral peak systolic tissue velocity (s'), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines., 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
47
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2013-04
|
| Completion Date: |
2015-12
|
| Results First Posted: |
2017-07-24
|
| Last Update Posted: |
2017-07-24
|
| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01754259
|
