Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

PHASE4CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Myocardial Perfusion ImagingMyocardial Ischemia
Interventions
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)"

DRUG

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

Trial Locations (43)

10032

Columbia University Medical Center, New York

11758

Dr. Michael Sacher, Massapequa

15213

University of Pittsburgh Medical Center Cardiovascular Institute, Pittsburgh

17011

Heritage Cardiology, Camp Hill

19713

Alfieri Cardiology, Newark

20520

Turku University Hospital, Turku

21804

Delmarva Heart Research Foundation, Inc, Salisbury

27710

Duke University Medical Center, Durham

31096

Rambam Health Care Campus, Haifa

32216

St. Luke's Cardiology Associates, Jacksonville

32806

Research One, Orlando

33173

Cardiovascular Research Center of South Florida, Miami

33449

Cardiology Partners Clinical Research Institute, Wellington

35294

University of Alabama at Birmingham, Birmingham

38305

Kore Cardiovascular Research, Jackson

42303

Research Integrity, LLC, Owensboro

60504

Fox Valley Clinical Research Center, LLC, Aurora

64111

Cardiovascular Imaging Technologies, Kansas City

69710

Assuta MC, Tel Aviv

70403

Louisiana Heart Center, Covington

70458

Louisiana Heart Center, Slidell

76100

Kaplan Medical Center, Rehovot

77002

East Texas Cardiology PA, Houston

78229

Mercury Medical, LLC, San Antonio

78278

Barzilai Medical Center, Ashkelon

80131

"Federico II University", Naples

Federico II University, Naples

84101

Soroka Medical Center, Beersheba

92251

Imperial Cardiac Center, Imperial

92691

Mission Internal Medical Group, Mission Viejo

93901

Central Coast Cardiology, Salinas

95648

Clinical Trials Research, Lincoln

119228

National University Health System, Singapore

168752

National Heart Centre Singapore, Singapore

04210

Androscroggin Cardiology Associates DBA Maine Research Associates, Auburn

02114

Massachusetts General Hospital, Boston

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

G7H 7P2

ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi

H1T 1C8

Montreal Heart Institute, Montreal

H2W 1T8

Chum Hotel Dieu, Montreal

100 34

University Hospital Kralovske Vinohrady, Prague

150 06

University Hospital Motol, Prague

HA1 3UJ

Northwick Park Hospital, Watford Road, Middlesex

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY