Recruiting

Ranolazine

Sponsor:

Amit Malhotra, MD

Code:

NCT03044964

Conditions

Angina

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ranolazine

Placebo

Study Details

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.

Conditions

Angina

Study ID

NCT03044964

Start date

Jan 10, 2017

Status verified date

Feb, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 -

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ranolazine

At randomization, patients will be started on 500mg of Ranolazine, twice daily for 1 week. After 1 week, the dosage may be increased to 1000mg of Ranolazine, twice daily for 5 weeks.

placebo comparator: Placebo

At Randomization, patients will be started on 500mg of a placebo, twice daily for 1 week. After 1 week, the dosage of the placebo may be increased to 1000mg, twice daily for 5 weeks.

Interventions

Ranolazine

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.

Placebo

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.

Primary outcome measure

  • Within-patient comparison of accelerometer-assessed physical activity utilizing the Actigraph accelerpmeter from baseline to end of study between Ranolazine and placebo. [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Stern Cardiovascular Foundation, Inc

Recruiting

Southaven, Mississippi, United States, 38671

Contacts

More Information

Sponsor

Amit Malhotra, MD

Last update posted

Feb 7, 2017

Last verified

Feb, 2017

Keywords

  • Angina, Chest Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amit Malhotra, MD on 2017-02-07.