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

February 3, 2017 updated by: Amit Malhotra, MD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Stern Cardiovascular Foundation, Inc
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yasar Cheema, MD
        • Sub-Investigator:
          • Dharmesh Patel, MD
        • Sub-Investigator:
          • Darrell Sneed, MD
        • Sub-Investigator:
          • Arie Szatkowski, MD
        • Sub-Investigator:
          • Justin May, MD
        • Sub-Investigator:
          • Gilbert Zoghbi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Ranexa
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amit Malhotra, MD

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Amit Malhotra, MD, Stern Cardiovascular Foundation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPTAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Angina

Clinical Trials on Ranolazine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe