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Study the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Perfusion Imaging; Myocardial Ischemia

Intervention: Placebo (Drug); Ranolazine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Jay Garg, MD, Study Director, Affiliation: Gilead Sciences

Overall contact:
Jennifer Meriwether, Phone: 1-650-524-3890, Email: jennifer.meriwether@gilead.com

Summary

The purpose of this study is to evaluate if ranolazine can improve blood flow to your heart (myocardial perfusion) by SPECT MPI when taken prior to exercise.

Clinical Details

Official title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Cross-over Trial to Evaluate the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

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

Primary outcome: Effect of ranolazine (versus placebo) on exercise-induced PDS

Secondary outcome: Effect of ranolazine (versus placebo) on SPECT MPI variables

Detailed description: To evaluate the effect of ranolazine 1000 mg administered twice daily compared to placebo on exercise-induced myocardial perfusion defect size (PDS), assessed by gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) in subjects with documented exercise induced myocardial ischemia at baseline.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Written informed consent prior to any study procedures

- Clinically indicated exercise SPECT MPI (stress and rest scans) performed within 4

weeks prior to screening

- At least 10% reversible myocardial ischemia on clinically indicated exercise SPECT

MPI study as confirmed by the core nuclear laboratory

- Stable doses of ≤ 2 antianginal medications (not including short-acting

nitroglycerin)

- Females of childbearing potential must agree to utilize highly effective

contraception methods from screening throughout the duration of study treatment and for 14 days following the last dose of study drug

- Able to perform exercise stress testing

Key Exclusion Criteria:

- Left bundle branch block

- Implantable cardiac defibrillator

- Pacemaker

- Intervening coronary revascularization between the time of their prior clinically

indicated exercise SPECT MPI study and Screening

- Acute myocardial infarction within 60 days prior to screening, or MI with planned

intervention during the duration of this study

- Unstable angina within 30 days prior to Screening

- Coronary artery bypass graft (CABG) surgery within 60 days prior to Screening or

percutaneous coronary intervention (PCI) within 30 days prior to Screening

- Anticipated coronary revascularization during the study period

- Cerebrovascular Attack (CVA) or Transient Ischemic Attack (TIA) within 90 days prior

to Screening

- Resting LVEF < 35%

- History of serious arrhythmias

- Currently in atrial fibrillation or atrial flutter

- QTc interval > 500 milliseconds

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

- Inability to exercise or exercise limitation due to other co morbidities that may

interfere with ability to perform exercise SPECT MPI study

- Body Mass Index (BMI) ≥ 38 kg/m2

- Any absolute contraindications to exercise stress testing

- Females who are pregnant, or breast-feeding

Locations and Contacts

Jennifer Meriwether, Phone: 1-650-524-3890, Email: jennifer.meriwether@gilead.com

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Misty Pruitt, Phone: 205-996-2311
Jack Heo, MD, Principal Investigator

Cardiovascular Research Foundation of Southern California, Beverly Hills, California 90210, United States; Recruiting
Judy Mao, Phone: 310-275-9551
Ronald Karlsberg, MD, Principal Investigator

Clinical Trials Research, Lincoln, California 95648, United States; Recruiting
Leesa Koskela, Phone: 916-781-6718
Jeffrey Wayne, MD, Principal Investigator

Mission Internal Medical Group, Mission Viejo, California 92691, United States; Recruiting
Rhodora Neu, CRC, Phone: 949-364-3388
Gregory S Thomas, MD, Principal Investigator

Hartford Hospital, Hartford, Connecticut 06102, United States; Recruiting
Deborah Katten, RN, Phone: 860-545-1537
Gary Heller, MD, Principal Investigator

Alfieri Cardiology, Newark, Delaware 19713, United States; Recruiting
Colleen Buchanan, Phone: 302-731-0001
Paul Alfieri, MD, Principal Investigator

Zasa Clinical Research, Boyton Beach, Florida 33472, United States; Recruiting
Susan Edwards, Phone: 561-964-7880
Debra Weinstein, MD, Principal Investigator

Jacksonville Cardiovascular Center, Jacksonville, Florida 32216, United States; Recruiting
Jewell Baker, Phone: 904-493-6555
Waddah Salman, MD, Principal Investigator

St. Luke's Cardiology Associates, Jacksonville, Florida 32216, United States; Recruiting
Melody Thompson, Phone: 904-296-0278, Ext: 236
Julius Dean, MD, Principal Investigator

Cardiovascular Research Center of South Florida, Miami, Florida 33173, United States; Recruiting
Ruben Dominguez, Phone: 305-275-8808
Karl Lembcke, MD, Principal Investigator

The Heart and Vascular Institute of Florida, St. Petersburg, Florida 33709, United States; Recruiting
Heather Harteneck, Phone: 727-490-2117
Peter Wassmer, MD, Principal Investigator

Cardiology Partners Clinical Research Institute, Wellington, Florida 33449, United States; Recruiting
Blake Liebeskind, Phone: 561-676-8913
Eliezer Hernandez, MD, Principal Investigator

Fox Valley Clinical Research Center, LLC, Aurora, Illinois 60504, United States; Recruiting
Bonnie Resch, Phone: 630-723-3485
Santosh Gill, MD, Principal Investigator

Cardiovascular Research of Northwest Indiana, LLC, Munster, Indiana 46321, United States; Recruiting
Ricardo Guedes, Phone: 219-934-4200
Wail Asfour, MD, Principal Investigator

Research Integrity, LLC, Owensboro, Kentucky 42303, United States; Recruiting
Julie Baker, Phone: 270-691-1827
Kisher Vora, MD, Principal Investigator

Louisiana Heart Center, Covington, Louisiana 70403, United States; Recruiting
Tasha Stevenson, Phone: 985-871-4155, Ext: 308
Marc Bernstein, MD, Principal Investigator

Louisiana Heart Center, Hammond, Louisiana 70403, United States; Recruiting
Tasha Stevenson, Phone: 985-370-7739, Ext: 113
Frank Arena, MD, Principal Investigator

Louisiana Heart Center, LaPlace, Louisiana 70068, United States; Withdrawn

Louisiana Heart Center, Slidell, Louisiana 70458, United States; Recruiting
Daphne Dureau, Phone: 985-649-2700, Ext: 213
Bruce Iteld, MD, Principal Investigator

Androscroggin Cardiology Associates DBA Maine Research Associates, Auburn, Maine 04210, United States; Recruiting
Jessica Gamache, Phone: 207-783-2795
Robert Weiss, MD, Principal Investigator

Delmarva Heart Research Foundation, Inc, Salisbury, Maryland 21804, United States; Recruiting
Kathryn Fiddler, Phone: 410-334-2333
M. Greg Treuth, MD, Principal Investigator

Great Lakes Research Group, Bay City, Michigan 48706, United States; Recruiting
Terri Vittitow, Phone: 989-895-9100
Jeffrey Potts, MD, Principal Investigator

Cardiovascular Imaging Technologies, Kansas City, Missouri 64111, United States; Recruiting
Staci Courter, Phone: 816-531-2842, Ext: 107
Timothy Bateman, MD, Principal Investigator

Albany Associates in Cardiology, Albany, New York 12205, United States; Withdrawn

Dr. Michael Sacher, Massapequa, New York 11758, United States; Recruiting
Regina Massaro, Phone: 516-882-9600
Michael Sacher, MD, Principal Investigator

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Magnolia Jimenez, Phone: 210-305-4275
Sabahat Bokhari, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Melissa Jenkins, Phone: 919-684-7752
Salvador Borges-Neto, MD, Principal Investigator

University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Amy Friesen, Phone: 513-558-5145
Myron Gerson, MD, Principal Investigator

University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada; Recruiting
Marlie Poirier, Phone: 613-761-5103
Terrence Ruddy, MD, Principal Investigator

Heritage Cardiology, Camp Hill, Pennsylvania 17011, United States; Recruiting
Kimberly Darrow, Phone: 717-441-1725
Venkatesh Nadar, MD, Principal Investigator

University of Pittsburgh Medical Center Cardiovascular Institute, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Louise Martin, Phone: 412-647-3435
Prem Soman, MD, Principal Investigator

ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital, Chicoutimi, Quebec G7H 7P2, Canada; Recruiting
Sophie Rousseau, Phone: 418-541-1024
Gerald Tremblay, MD, Principal Investigator

Chum Hotel Dieu, Montreal, Quebec H2W 1T8, Canada; Recruiting
Renee Duclos, Phone: 514-890-8000, Ext: 14803
Carol Lemay, Phone: 514-890-8000, Ext: 14803
Samer Mansour, MD, Principal Investigator

Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada; Recruiting
Nathalie Nadeau, Phone: 1-514-376-3330, Ext: 3214
Jean Gregoire, MD, Principal Investigator

Kore Cardiovascular Research, Jackson, Tennessee 38305, United States; Recruiting
Donna Manns, Phone: 731-512-0104
Elie Hage-Korban, MD, Principal Investigator

Meharry Medical College, Nashville, Tennessee 37208, United States; Recruiting
Denise Clarke, Phone: 615-327-6884
John Murray, MD, Principal Investigator

Cardiovascular Associates of East Texas, P.A., Tyler, Texas 75701, United States; Recruiting
James Crump, Phone: 905-595-2283
Scott Wright, MD, Principal Investigator

University of Virginia Health System, Charlottesville, Virginia 22908, United States; Recruiting
Jayne Missel, Phone: 434-243-7195
Jamieson Bourque, MD, Principal Investigator

Clinical Research Associates of Tidewater, Norfolk, Virginia 23507, United States; Withdrawn

Additional Information

Starting date: September 2010
Last updated: November 7, 2011

Page last updated: December 08, 2011

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