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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01221272
Other study ID # GS-US-259-0103
Secondary ID
Status Completed
Phase Phase 4
First received October 13, 2010
Last updated August 21, 2014
Start date September 2010
Est. completion date September 2012

Study information

Verified date August 2014
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review CommitteeCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlFinland: Ethics CommitteeFinland: Finnish Medicines AgencyIsrael: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeItaly: The Italian Medicines AgencySingapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

This study enrolled participants with documented exercise-induced myocardial ischemia in order to evaluate whether ranolazine, when taken prior to exercise, can improve blood flow to the heart (myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

This was a 2-period crossover study. The last dose of each period must have been taken 3-4 hours prior to conduct of the exercise SPECT MPI. After the research exercise SPECT MPI was performed at the end of Period 1, participants discontinued the treatment they were randomized to for that period and began the other treatment in Period 2.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Key Inclusion Criteria:

- Exercise SPECT MPI study (stress and rest) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory using Corridor4DM imaging software) performed not more than 12 weeks prior to screening, OR

- Exercise SPECT MPI study (stress and rest) conducted during screening (after consultation with the Medical Monitor and after informed consent was obtained) showing at least 10% reversible myocardial ischemia (as confirmed by the core nuclear laboratory)

- Stable antianginal medical therapy (excluding short-acting nitroglycerin)

Key Exclusion Criteria:

- Left bundle branch block

- Automated implantable defibrillator and/or pacemaker (selected subjects with permanent pacemakers who had an intact sinus mechanism may have been included following consultation with the Medical Monitor)

- Intervening coronary revascularization between the time of qualifying exercise SPECT MPI study and randomization

- Acute myocardial infarction (MI) within 60 days prior to screening or at any time after the qualifying exercise SPECT MPI study, or MI undergoing staged intervention during a subject's participation in the trial

- Unstable angina within 30 days prior to screening, or at any time after the qualifying exercise SPECT MPI study

- Coronary artery bypass graft surgery within 60 days prior to screening or at any time after the qualifying exercise SPECT MPI study, or percutaneous coronary intervention within 30 days prior to screening or at any time after the qualifying exercise SPECT MPI study

- Anticipated coronary revascularization during the trial period

- Cerebrovascular attack or transient ischemic attack within 90 days prior to screening

- History of serious arrhythmias

- Current atrial fibrillation or atrial flutter

- QTc interval > 500 milliseconds

- Diagnosed as having New York Heart Association Class III or IV heart failure

- Inability to exercise or exercise limitation due to other comorbidities that may have interfered with ability to perform required exercise SPECT MPI study

- Body mass index greater than or equal to 38 kg/m^2 (may have been up to 40 kg/m^2 after consultation with the Medical Monitor)

- Any absolute contraindications to exercise stress testing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Ranolazine
One 500 mg tablet in the evening on Day 1 of the period One 500 mg tablet, twice daily on Days 2-3 of the period Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days)
Placebo to match ranolazine
Placebo to match ranolazine administered in the same form and frequency as the active drug.
Procedure:
SPECT MPI
Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits.
Behavioral:
Exercise
Treadmill stress test

Locations

Country Name City State
Canada ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital Chicoutimi Quebec
Canada Chum Hotel Dieu Montreal Quebec
Canada Montreal Heart Institute Montreal Quebec
Canada University of Ottawa Heart Institute Ottawa Ontario
Czech Republic University Hospital Kralovske Vinohrady Praha 10
Czech Republic University Hospital Motol Praha 5
Finland Turku University Hospital Turku
Israel Barzilai Medical Center Ashkelon
Israel Soroka Medical Center Beer Sheva
Israel Rambam Health Care Campus Haifa
Israel Kaplan Medical Center Rehovot
Israel Assuta MC Tel Aviv
Italy "Federico II" University Naples
Italy Federico II University Naples
Singapore National Heart Centre Singapore Singapore
Singapore National University Health System Singapore
United Kingdom Northwick Park Hospital, Watford Road Middlesex
United States Androscroggin Cardiology Associates DBA Maine Research Associates Auburn Maine
United States Fox Valley Clinical Research Center, LLC Aurora Illinois
United States University of Alabama at Birmingham Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Heritage Cardiology Camp Hill Pennsylvania
United States Louisiana Heart Center Covington Louisiana
United States Duke University Medical Center Durham North Carolina
United States East Texas Cardiology PA Houston Texas
United States Imperial Cardiac Center Imperial California
United States Kore Cardiovascular Research Jackson Tennessee
United States St. Luke's Cardiology Associates Jacksonville Florida
United States Cardiovascular Imaging Technologies Kansas City Missouri
United States Clinical Trials Research Lincoln California
United States Dr. Michael Sacher Massapequa New York
United States Cardiovascular Research Center of South Florida Miami Florida
United States Mission Internal Medical Group Mission Viejo California
United States Columbia University Medical Center New York New York
United States Alfieri Cardiology Newark Delaware
United States Research One Orlando Florida
United States Research Integrity, LLC Owensboro Kentucky
United States University of Pittsburgh Medical Center Cardiovascular Institute Pittsburgh Pennsylvania
United States Central Coast Cardiology Salinas California
United States Delmarva Heart Research Foundation, Inc Salisbury Maryland
United States Mercury Medical, LLC San Antonio Texas
United States Louisiana Heart Center Slidell Louisiana
United States Cardiology Partners Clinical Research Institute Wellington Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Finland,  Israel,  Italy,  Singapore,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods. Up to 33 days No
Primary Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods. Up to 33 days No
Secondary Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2 Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2. Up to 33 days No
Secondary Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2 Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2. Up to 33 days No
Secondary Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2 Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2. Up to 33 days No
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