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

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ClinicalTrials.gov Identifier: NCT03044964
Recruitment Status : Unknown
Verified February 2017 by Amit Malhotra, MD, Stern Cardiovascular Foundation, Inc..
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Amit Malhotra, MD, Stern Cardiovascular Foundation, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Angina Drug: Ranolazine Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Ranolazine

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044964


Contacts
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Contact: Amit Malhotra, MD 901-271-5468 amit.malhotra@sterncardio.com
Contact: Diana Barker, LPN 901-271-5468 diana.barker@sterncardio.com

Locations
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United States, Mississippi
Stern Cardiovascular Foundation, Inc Recruiting
Southaven, Mississippi, United States, 38671
Contact: Amit Malhotra, MD    901-271-1000    amit.malhotra@sterncardio.com   
Contact: Diana Barker, LPN    901-271-1000    diana.barker@sterncardio.com   
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         
Sponsors and Collaborators
Amit Malhotra, MD
Gilead Sciences
Investigators
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Principal Investigator: Amit Malhotra, MD Stern Cardiovascular Foundation, Inc.
More Information
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Publications:
Belardinelli L, et al. Eur Heart J. 2004;6(suppl I):I3-I7.
Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV, Anderson JL; American College of Cardiology Foundation/American Heart Association Task Force. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012 Dec 18;126(25):e354-471. doi: 10.1161/CIR.0b013e318277d6a0. Epub 2012 Nov 19. Erratum in: Circulation. 2014 Apr 22;129(16):e463.

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Responsible Party: Amit Malhotra, MD, Sponsor-Investigator, Stern Cardiovascular Foundation, Inc.
ClinicalTrials.gov Identifier: NCT03044964    
Other Study ID Numbers: REPTAR
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amit Malhotra, MD, Stern Cardiovascular Foundation, Inc.:
Angina, Chest Pain
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
 Pain
Neurologic Manifestations
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action