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Status:

COMPLETED

Ranolazine Among Unrevascularized Chronic Stable Angina Patients

Lead Sponsor:

North Florida Foundation for Research and Education

Collaborating Sponsors:

Gilead Sciences

Conditions:

Angina

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves an...

Detailed Description

This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves an...

Eligibility Criteria

Inclusion

  • Adult patients \>= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
  • At least 1 indeterminate stenosis (20-80%),
  • Fractional flow reserve (FFR) \<=0.8 and PCI deferred

Exclusion

  • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
  • acute coronary syndrome or cardiogenic shock
  • QTc \> 500 milliseconds
  • use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
  • use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
  • liver cirrhosis
  • sever renal insufficiency (i.e. creatinine clearance \< 30mL/min/1.73 m2)

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2016

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT02265796

Start Date

September 1 2014

End Date

September 1 2016

Last Update

August 22 2019

Active Locations (1)

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North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States, 32608