Clinical trial NCT01221272: Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Perfusion Imaging
Myocardial Ischemia
Keywords: SPECT MPI
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment
timeFrame: Up to 33 days
measure: Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment
timeFrame: Up to 33 days
Secondary outcomes:
measure: Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2
timeFrame: Up to 33 days
measure: Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2
timeFrame: Up to 33 days
measure: Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2
timeFrame: Up to 33 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Imperial
country: United States
facility: Imperial Cardiac Center
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Salinas
country: United States
facility: Central Coast Cardiology
state: California
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Jacksonville
country: United States
facility: St. Luke's Cardiology Associates
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Orlando
country: United States
facility: Research One
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center, LLC
state: Illinois
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Covington
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Slidell
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Auburn
country: United States
facility: Androscroggin Cardiology Associates DBA Maine Research Associates
state: Maine
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation, Inc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Cardiovascular Imaging Technologies
state: Missouri
city: Massapequa
country: United States
facility: Dr. Michael Sacher
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Camp Hill
country: United States
facility: Heritage Cardiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Cardiovascular Institute
state: Pennsylvania
city: Jackson
country: United States
facility: Kore Cardiovascular Research
state: Tennessee
city: Houston
country: United States
facility: East Texas Cardiology PA
state: Texas
city: San Antonio
country: United States
facility: Mercury Medical, LLC
state: Texas
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Chicoutimi
country: Canada
facility: ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Chum Hotel Dieu
state: Quebec
city: Praha 10
country: Czech Republic
facility: University Hospital Kralovske Vinohrady
city: Praha 5
country: Czech Republic
facility: University Hospital Motol
city: Turku
country: Finland
facility: Turku University Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Assuta MC
city: Naples
country: Italy
facility: "Federico II" University
city: Naples
country: Italy
facility: Federico II University
city: Singapore
country: Singapore
facility: National University Health System
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Middlesex
country: United Kingdom
facility: Northwick Park Hospital, Watford Road
Study officials:
affiliation: Gilead Sciences
name: Patrick Yue, MD
role: STUDY_DIRECTOR
References: