Angina
Conditions
Keywords
Angina, Chest Pain
Brief summary
The post-marketing study is designed to evaluate the activity level and exercise tolerance of patients with deferred percutaneous intervention due to FFR (fractional flow reserve) greater or equal to 0.81 and treatment with Ranolazine versus placebo.
Detailed description
Ranolazine was approved as Ranexa in the United States on January 31, 2006 for the treatment of chronic angina. This post-marketing study is a single-center, double-blind, prospective, randomized, parallel-group evaluation of patients randomized 1:1 between Ranolazine and placebo.
Interventions
DRUGRanolazine
Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.
DRUGPlacebo
Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.
Sponsors
Gilead Sciences
Amit Malhotra, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be willing and able to comply with schedules visits, treatment plan, and other study procedures. 2. There must be evidence of personally signed and dated informed consent documents. 3. Subjects must have a documented history of anginal chest pain equal to or greater than one (1) episode per week prior to cardiac catheterization. 4. Subjects must have greater than or equal to one (1) episode of angina chest pain between screening visit and randomization visit. 5. Subject must have documented cardiac catheterization with deferred percutaneous intervention and fractional flow reserve (FFR) greater than or equal to 0.81 within thirty (30) days, or an (FFR) less than 0.81if not a candidate for revascularization based upon operator discretion. \-
Exclusion criteria
1. Subjects with a congenital or acquired QT interval prolongation (greater than or equal to 440ms in men/greater than or equal to 460ms in women). 2. Subjects prescibed strong CYP3A inhibitors (including ketaconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir and saquinavir.) and/or strong CYP3A inducers (rifampin, rifabutin, rifapentin, Phenobarbital, phenytoin, carbamezepine and St. John's wort). 3. Subjects prescribed to Simvastatin (Zocor) that cannot have dose reduced to appropriate levels (20mg QD) per physician or have medication discontinued during the clinical trial. 4. Subjects prescribed Metformin that cannot have dose reduced to appropriate levels (less than or equal to 850mg BID) per physician or have medication discontinued during the clinical trial. 5. Subjects prescribed Digoxin that cannot have dose reduced to appropriate levels (0.125mg QD) per physician or have medication discontinued during the clinical trial. 6. Subjects with life expectancy less than the duration of the trial. 7. Subjects with a history of liver cirrhosis. 8. Subject with chronic renal disease with creatinine clearance of less than 30mL/min. 9. Subjects participating in any other clinical trial for the duration of the trial. 10. Females who are of childbearing potential, who are unwilling or unable to use highly effective method of contraception -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Within-patient comparison of accelerometer-assessed physical activity utilizing the Actigraph accelerpmeter from baseline to end of study between Ranolazine and placebo. | 8 weeks |
Countries
United States
Contacts
Primary ContactAmit Malhotra, MD
Backup ContactDiana Barker, LPN
Outcome results
None listed