Ranolazine Among Unrevascularized Chronic Stable Angina Patients

NCT ID: NCT02265796

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-09-30

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

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 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.

Baseline Procedure:

Assessments performed exclusively to determine eligibility for this study would be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. The assessment will include:

• Informed Consent
• Review subject eligibility criteria
• FFR value calculated at the time of cardiac catheterization
• Review previous and concomitant medications
• Frequency of symptoms and quality of life prior to study according to Seattle Angina Questionnaire (SAQ)

Screening Visit:

The assessments to determine eligibility are:

• Review of eligibility criteria
• Review of cardiac catheterization and FFR
• Review of medications taken in the past 30 days Subjects that meet eligibility criteria will be randomized to receive either the active drug, Ranolazine or a matching placebo (non-active drug). Staff and subjects will not know if the subject will be receiving the active drug or the placebo.

Drug schedule will be as follows:

• 1st dose of one tablet (500mg) will begin the evening of Day 1
• On Days 2-7, one tablet (500mg) two times a day (12-hours apart).
• On Day 8, increase dose of study drug to two tablets (1000mg) twice a day; once in the morning and once in the evening, 12 hours apart. This dose will continue for the duration of the study. The study drug can be taken with or without food.

Telephone Follow-up:

One week phone calls will be made to determine well being, adverse events, answer questions and remind subjects to increase the study medication dose.

Month 4 Follow-up:

• Frequency of symptoms and quality of life according to Seattle Angina Questionnaire (SAQ)
• Assessment of well-being
• Any hospitalizations or the need for revascularization

Conditions

Angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine

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

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: 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

Sugar pill

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

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: DRUG

1. 500mg tablet two times per day for 7 days then,

2. 500mg tablet (1000mg) two times per day for 15 weeks

Interventions

Ranolazine

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

Intervention Type: DRUG

Sugar pill

1. 500mg tablet two times per day for 7 days then,

2. 500mg tablet (1000mg) two times per day for 15 weeks

Intervention Type: DRUG

Other Intervention Names

Ranexa; placebo

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

North Florida Foundation for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Anthony A Bavry

Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony A Bavry, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28044265 (View on PubMed)

Other Identifiers

149-2013

Identifier Type: -

Identifier Source: org_study_id