Ranolazine Among Unrevascularized Chronic Stable Angina Patients

NCT02265796 | Completed Phase 2 Results

• 1 other identifier: 149-2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization

Conditions

Angina

Keywords

deferred percutaneous coronary intervention; fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks

  The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). .

  Change in baseline to 16 weeks

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 500 mg tablets 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

Ranolazine 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

Also known as: Ranexa

Ranolazine

Sugar pill DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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)

Sponsors & Collaborators

• North Florida Foundation for Research and Education: lead
• Gilead Sciences: collaborator

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Bavry AA, Park KE, Choi CY, Mahmoud AN, Wen X, Elgendy IY. Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia (IMWELL Study). Cardiol Ther. 2017 Jun;6(1):81-88. doi: 10.1007/s40119-016-0081-3. Epub 2017 Jan 2.

  PMID: 28044265 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris

Interventions

Ranolazine; Sugars

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Anthony Bavry
• Organization: Malcom Randall VA Medical Center

anthony.bavry@va.gov

352-376-1611

Study Officials

• Anthony A Bavry, MD, MPH

  NorthFlorida/South Georgia Veterans Health System, Gainesville, FL 32608

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 22, 2019
• Results First Posted: December 4, 2017

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)