NCT02147834

Brief Summary

To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 22, 2014

Results QC Date

May 22, 2019

Last Update Submit

May 22, 2019

Conditions

Angina

Keywords

deferred percutaneous coronary interventionfractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • Seattle Angina Questionnaire Score Change From Baseline to Month 4

    The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).

    Change in baseline to month 4

Secondary Outcomes (2)

  • Subjective Well Being

    Compare from baseline to month 4

  • Ischemia Driven Revascularization or Hospitalization

    4 month

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks

Drug: Ranolazine

Sugar pill

PLACEBO COMPARATOR

Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks

Drug: Sugar pill

Interventions

RanolazineDRUG

Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks

Also known as: Ranexa
Ranolazine
Sugar pillDRUG

sugar pill manufactured to mimic ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks

Also known as: placebo
Sugar pill

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable 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

You may not qualify if:

  • 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
  • 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 insufficience (i.e. creatinine clearance \< 30mL/min/1.73 m2)
  • QTc \> 500 milliseconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

RanolazineSugars

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Anthony A Bavry, M.D.
Organization
North Florida South Georigai Veteran Health System
anthony.bavry@va.gov
352-548-6000

Study Officials

  • Anthony A Bavry, MD, MPH

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 28, 2014

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

June 11, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-05

Locations

US(1)