Myocardial Perfusion ImagingPhase 4NCT01221272
Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging
A Phase 4 study testing Ranolazine, SPECT MPI and Exercise in people with Myocardial Perfusion Imaging and Myocardial Ischemia, run by Gilead Sciences at 43 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion Imaging, Myocardial Ischemia
- What is being tested?
- Ranolazine, SPECT MPI and Exercise
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 43 sitesin 8 countries
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
43 sites in 8 countries.
43 sites in 8 countries
United States26 sites
Androscroggin Cardiology Associates DBA Maine Research Associates
Auburn, Maine, 04210
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, 60504
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Heritage Cardiology
Camp Hill, Pennsylvania, 17011
Louisiana Heart Center
Covington, Louisiana, 70403
Duke University Medical Center
Durham, North Carolina, 27710
East Texas Cardiology PA
Houston, Texas, 77002
Imperial Cardiac Center
Imperial, California, 92251
Kore Cardiovascular Research
Jackson, Tennessee, 38305
St. Luke's Cardiology Associates
Jacksonville, Florida, 32216
Cardiovascular Imaging Technologies
Kansas City, Missouri, 64111
Clinical Trials Research
Lincoln, California, 95648
Dr. Michael Sacher
Massapequa, New York, 11758
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
Mission Internal Medical Group
Mission Viejo, California, 92691
Columbia University Medical Center
New York, New York, 10032
Alfieri Cardiology
Newark, Delaware, 19713
Research One
Orlando, Florida, 32806
Research Integrity, LLC
Owensboro, Kentucky, 42303
University of Pittsburgh Medical Center Cardiovascular Institute
Pittsburgh, Pennsylvania, 15213
Central Coast Cardiology
Salinas, California, 93901
Delmarva Heart Research Foundation, Inc
Salisbury, Maryland, 21804
Mercury Medical, LLC
San Antonio, Texas, 78229
Louisiana Heart Center
Slidell, Louisiana, 70458
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Israel5 sites
Barzilai Medical Center
Ashkelon, 78278
Soroka Medical Center
Beersheba, 84101
Rambam Health Care Campus
Haifa, 31096
Kaplan Medical Center
Rehovot, 76100
Assuta MC
Tel Aviv, 69710
Canada4 sites
ECOGENE-21 Clinical Trial Center, Chicoutimi Hospital
Chicoutimi, Quebec, G7H 7P2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Chum Hotel Dieu
Montreal, Quebec, H2W 1T8
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Czechia2 sites
University Hospital Kralovske Vinohrady
Prague, 100 34
University Hospital Motol
Prague, 150 06
Italy2 sites
"Federico II" University
Naples, 80131
Federico II University
Naples, 80131
Singapore2 sites
National University Health System
Singapore, 119228
National Heart Centre Singapore
Singapore, 168752
United Kingdom1 site
Northwick Park Hospital, Watford Road
Middlesex, HA1 3UJ
About this study
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
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.
- Conditions
- Myocardial Perfusion Imaging, Myocardial Ischemia
- Being tested
- Ranolazine, Placebo to match ranolazine, SPECT MPI, Exercise
- Keywords
- SPECT MPI
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa®
- 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 ranolazineDrug
Placebo to match ranolazine administered in the same form and frequency as the active drug.
SPECT MPIProcedure or surgery
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.
ExerciseBehavioural
Treadmill stress test
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine/Placebo | Experimental | Participants received ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. Receives: Drug: Ranolazine; Drug: Placebo to match ranolazine; Procedure: SPECT MPI; Behavioral: Exercise |
| Placebo/Ranolazine | Experimental | Participants received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. Receives: Drug: Ranolazine; Drug: Placebo to match ranolazine; Procedure: SPECT MPI; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 33 days
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.
Measured: Up to 33 days
Secondary outcomes (3)
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.
Measured: Up to 33 days
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.
Measured: Up to 33 days
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.
Measured: Up to 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial Perfusion ImagingStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Yue, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221272
- Sponsor's protocol ID
- GS-US-259-0103
- Status last verified
- Aug 2014
- First submitted
- 13 Oct 2010
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01221272
- Acronym / sponsor ID
- GS-US-259-0103
- Conditions
- Myocardial Perfusion Imaging, Myocardial Ischemia
- Keywords
- SPECT MPI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Posted 3 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine/Placebo | Experimental | Drug: Ranolazine, Drug: Placebo to match ranolazine, Procedure: SPECT MPI, Behavioral: ExerciseParticipants received ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. |
| Placebo/Ranolazine | Experimental | Drug: Ranolazine, Drug: Placebo to match ranolazine, Procedure: SPECT MPI, Behavioral: ExerciseParticipants received placebo to match ranolazine from Day 1 through Day 15 (± 2 days) of Period 1, followed by an exercise SPECT MPI study, then received ranolazine from Day 1 through Day 15 (± 2 days) of Period 2, followed by an exercise SPECT MPI study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: Ranexa®* 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/Ranolazine, Ranolazine/Placebo |
| Placebo to match ranolazinePlacebo to match ranolazine administered in the same form and frequency as the active drug. | Drug | Placebo/Ranolazine, Ranolazine/Placebo |
| SPECT MPIGated 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. | Procedure or surgery | Placebo/Ranolazine, Ranolazine/Placebo |
| ExerciseTreadmill stress test | Behavioural | Placebo/Ranolazine, Ranolazine/Placebo |
Primary outcome
Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment
Time frame: Up to 33 days
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.
Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment
Time frame: Up to 33 days
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.
3 secondary outcomes
Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2
Time frame: Up to 33 days
Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2
Time frame: Up to 33 days
Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2
Time frame: Up to 33 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myocardial Perfusion Imaging
Not yet recruitingObservational study
Replacing Spatial Filtering With Deep-learning Noise Reduction
Cardiac Disease
Recruiting
Quantitative Myocardial Perfusion Imaging Assessment by SPECT/CT
Coronary Artery Disease, Chronic Coronary Syndrome
RecruitingPhase 4
Vericiguat and Reverse Remodeling Indices in Heart Failure
Heart Failure With Reduced Ejection Fraction (HFrEF), Chronic Heart Failure
Active, not recruitingObservational study
Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
Coronary Disease, Percutaneous Coronary Intervention
RecruitingObservational study
Validation of Myocardial Perfusion and Extracellular Volume Assessment Using Photon-Counting Computed Tomography (PCCT) Compared With Cardiac Magnetic Resonance (CMR) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Myocardial Diseases, Perfusion Imaging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Yue, MD study director
Gilead Sciences
43 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine, SPECT MPI and Exercise in people with Myocardial Perfusion Imaging and Myocardial Ischemia, run by Gilead Sciences at 43 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Israel, Canada, Czechia, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment (time frame: Up to 33 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.