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Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR) (REPTAR)

Primary Purpose

Angina

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ranolazine

Placebo

About this trial

This is an interventional treatment trial for Angina focused on measuring Angina, Chest Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must be willing and able to comply with schedules visits, treatment plan, and other study procedures.
There must be evidence of personally signed and dated informed consent documents.
Subjects must have a documented history of anginal chest pain equal to or greater than one (1) episode per week prior to cardiac catheterization.
Subjects must have greater than or equal to one (1) episode of angina chest pain between screening visit and randomization visit.
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:

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).
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).
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.
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.
Subjects prescribed Digoxin that cannot have dose reduced to appropriate levels (0.125mg QD) per physician or have medication discontinued during the clinical trial.
Subjects with life expectancy less than the duration of the trial.
Subjects with a history of liver cirrhosis.
Subject with chronic renal disease with creatinine clearance of less than 30mL/min.
Subjects participating in any other clinical trial for the duration of the trial.
Females who are of childbearing potential, who are unwilling or unable to use highly effective method of contraception -

Sites / Locations

Stern Cardiovascular Foundation, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Within-patient comparison of accelerometer-assessed physical activity utilizing the Actigraph accelerpmeter from baseline to end of study between Ranolazine and placebo.

Secondary Outcome Measures

Full Information

NCT ID

NCT03044964

First Posted

January 26, 2017

Last Updated

February 3, 2017

Sponsor

Amit Malhotra, MD

Collaborators

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03044964

Brief Title

Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)

Acronym

REPTAR

Official Title

Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 10, 2017 (Actual)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Amit Malhotra, MD

Collaborators

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Angina

Keywords

Angina, Chest Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ranolazine

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ranolazine

Other Intervention Name(s)

Ranexa

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be willing and able to comply with schedules visits, treatment plan, and other study procedures. There must be evidence of personally signed and dated informed consent documents. Subjects must have a documented history of anginal chest pain equal to or greater than one (1) episode per week prior to cardiac catheterization. Subjects must have greater than or equal to one (1) episode of angina chest pain between screening visit and randomization visit. 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: 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). 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). 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. 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. Subjects prescribed Digoxin that cannot have dose reduced to appropriate levels (0.125mg QD) per physician or have medication discontinued during the clinical trial. Subjects with life expectancy less than the duration of the trial. Subjects with a history of liver cirrhosis. Subject with chronic renal disease with creatinine clearance of less than 30mL/min. Subjects participating in any other clinical trial for the duration of the trial. Females who are of childbearing potential, who are unwilling or unable to use highly effective method of contraception -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amit Malhotra, MD

Phone

901-271-5468

amit.malhotra@sterncardio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Diana Barker, LPN

Phone

901-271-5468

diana.barker@sterncardio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amit Malhotra, MD

Organizational Affiliation

Stern Cardiovascular Foundation, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stern Cardiovascular Foundation, Inc

City

Southaven

State/Province

Mississippi

ZIP/Postal Code

38671

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amit Malhotra, MD

Phone

901-271-1000

amit.malhotra@sterncardio.com

First Name & Middle Initial & Last Name & Degree

Diana Barker, LPN

Phone

901-271-1000

diana.barker@sterncardio.com

First Name & Middle Initial & Last Name & Degree

Yasar Cheema, MD

First Name & Middle Initial & Last Name & Degree

Dharmesh Patel, MD

First Name & Middle Initial & Last Name & Degree

Darrell Sneed, MD

First Name & Middle Initial & Last Name & Degree

Arie Szatkowski, MD

First Name & Middle Initial & Last Name & Degree

Justin May, MD

First Name & Middle Initial & Last Name & Degree

Gilbert Zoghbi, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)

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