Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
TERISA
A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel Study of Ranolazine in Subjects With Chronic Stable Angina and Coronary Artery Disease With a History of Type 2 Diabetes Mellitus
1 other identifier
interventional
949
13 countries
132
Brief Summary
This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Shorter than P25 for phase_4
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 30, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
November 4, 2014
CompletedNovember 4, 2014
October 1, 2014
1.1 years
August 24, 2011
October 20, 2014
October 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment
Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks. For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject's actual duration of treatment.
6 weeks
Secondary Outcomes (5)
Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment
6 weeks
Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency
6 weeks
Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency
6 weeks
Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores
Up to 8 weeks
Patient's Global Impression of Change (PGIC) Scale Score
8 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORQualifying phase: Participants will enter a 2-week washout period if needing to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period will be randomized to the treatment period. Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks.
Ranolazine
EXPERIMENTALQualifying phase: Participants will enter a 2-week washout period if needing to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period will be randomized to the treatment period. Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Males and females aged at least 18 years
- At least a 3-month history of chronic stable angina triggered by physical effort and relieved by rest and/or sublingual nitroglycerin
- CAD documented by one or more of the following:
- Angiographic evidence of ≥ 50% stenosis of one or more major coronary arteries
- History of myocardial infarction (MI) documented by positive myocardial muscle creatine kinase (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
- Cardiac imaging study or exercise test diagnostic for CAD
- Treatment with up to 2 antianginal therapies at a stable dose for at least 2 weeks prior to the Qualifying Period.
- Documented history of T2DM
- Willing to maintain stable tobacco usage habits throughout the study
- Willing to maintain stable activity levels throughout the study
- 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.
You may not qualify if:
- New York Heart Association (NYHA) Class III and IV
- Acute coronary syndrome in the prior 2 months or planned coronary revascularization during the study period
- Stroke or transient ischemic attack within 6 months prior to Screening
- QTc \> 500 milliseconds
- Uncontrolled hypertension (seated systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
- Systolic blood pressure \< 100 mmHg
- Clinically significant hepatic impairment
- Prior treatment with ranolazine, or known hypersensitivity or intolerance to ranolazine
- Females who are breastfeeding
- Positive serum pregnancy test
- Participation in another investigational drug or device study within 1 month prior to Screening
- Current treatment with trimetazidine, ivabradine, or nicorandil. Subjects will need to discontinue these medications 2 weeks prior to the Qualifying Period.
- Current treatment with potent inhibitors of cytochrome (CYP)3A (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir)
- Current treatment with CYP3A and P glycoprotein (Pgp) inducers (eg, rifampicin/rifampin, carbamazepine, and St. John's wort \[Hypericum perforatum\])
- Current treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, and sirolimus)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (135)
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204, United States
Merced Heart Associates
Merced, California, 95340, United States
Spectrum Clinical Research Institute, Inc
Moreno Valley, California, 92553, United States
Sacramento Heart and Vascular Research Center
Sacramento, California, 95825, United States
South Florida Research Solutions, LLC
Hollywood, Florida, 33021, United States
Baptist Heart Specialist
Jacksonville, Florida, 32207, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, 30909, United States
Columbus Cardiology Associates
Columbus, Georgia, 31909, United States
Central Cardiology Associates
Elizabethtown, Kentucky, 42701, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301, United States
Clinical Trials Management, LLC
Mandeville, Louisiana, 70471, United States
Endeavor Medical Research, PLC
Alpena, Michigan, 49707, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Cross Country Cardiology
Edgewater, New Jersey, 07020, United States
Kore CV Research
Jackson, Tennessee, 38305, United States
Wellmont Cardiovascular Associates Heart Institute
Johnson City, Tennessee, 37604, United States
Med-Tech Research
Houston, Texas, 77024, United States
Humble Cardiology Associates
Humble, Texas, 77338, United States
State Institution "Gomel regional clinical hospital"
Homyel, 246029, Belarus
State Inst Rep Scientific and Practical center
Minsk, 220036, Belarus
Diagnostic Consultative Center, Ascendent Cardiological Out-Patient Office
Sofia, 1202, Bulgaria
MHAT "Tsar Boris III"
Sofia, 1233, Bulgaria
National Cardiology Center, Cardiology Clinic - III
Sofia, 1309, Bulgaria
MHAT "Vita", Cardiology Department
Sofia, 1505, Bulgaria
UMHAT "Tsaritsa Yoanna" - ISUL, Cardiology Clinic
Sofia, 1527, Bulgaria
Military Medical Academy, Clinic of Cardiology and Intesive Care
Sofia, 1606, Bulgaria
Dr. Roger Labonté Professional Medicine Corp.
Greater Sudbury, Ontario, P3E 3B8, Canada
SKDS Research Inc
Newmarket, Ontario, L3Y 5G8, Canada
Aniol Gupta MD
Toronto, Ontario, M9V 4B4, Canada
Montréal General Hospital
Montreal, Quebec, H3G 1A4, Canada
High Desert Medical Group
Lancaster, 93534, Canada
Montreal Heart Institute
Montreal, H1T 1C8, Canada
London Road Diagnostic Clinic and Medical Centre
Ontario, N7T 4X3, Canada
Topsail Road Medical Clinic
St. John's, A1E 2E2, Canada
Vojenska Nemocnice Brno
Brno, 636 00, Czechia
Cardiocentrum Kladno s.r.o.
Kladno, 27280, Czechia
Poliklinika Modrany - Kardiologie
Prague, 14300, Czechia
Fakultní Nemocnice v Motole
Prague, 150 06, Czechia
Corintez s.r.o.
Prague, 158 00, Czechia
Centrum klinického výzkumu, s.r.o.
Príbram, 26101, Czechia
Nemocnice Slaný
Slaný, 27401, Czechia
Tbilisi State Medical University Alexandre Aladashvili University Clinic
Tbilisi, 0102, Georgia
Amtel Hospital First Clinical LLC
Tbilisi, 0144, Georgia
Clinic "Guli"
Tbilisi, 0144, Georgia
Cardio-Reanimation Clinic LTD
Tbilisi, 0159, Georgia
Emergency Cardiology Center by Academician G. Chapidze LTD
Tbilisi, 0159, Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi, 0159, Georgia
Multiprofile Clinical Hospital of Tbilisi #2 LTD
Tbilisi, 0164, Georgia
Charité Campus Virchow Klinikum
Berlin, 13353, Germany
Städtische Kliniken Bielefeld
Bielefeld, 33604, Germany
Sankt Johannes-Hospital Dortmund
Dortmund, 44137, Germany
Universitätsklinikum Göttingen
Göttingen, 37099, Germany
Gemeinschaftspraxis fur Kardiologie
Heidelberg, 69115, Germany
Praxis Fur Innere Medizin Kardiologie, Pneumologic und Allergologie
Mannheim, 68165, Germany
Universitätsmedizin Mannheim
Mannheim, 68169, Germany
Barzilai Medical Center, Cardiology Dept.
Ashkelon, 78287, Israel
Assaf Harofeh Medical Centre
Be’er Ya‘aqov, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, 91004, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Ziv Medical Center
Safed, 13100, Israel
Tel Aviv Souraski Medical Center
Tel Aviv, 64239, Israel
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
Krakow, Lesser Poland Voivodeship, 30-082, Poland
NZOZ Revita Poradnia Kardiologiczna
Krakow, Lesser Poland Voivodeship, 31-949, Poland
KO-MED Marek Konieczny
Puławy, Lublin Voivodeship, 24-100, Poland
Instytut Kardiologii
Warsaw, Masovian Voivodeship, 02-637, Poland
Instytut Kardiologii
Warsaw, Masovian Voivodeship, 04-628, Poland
NZOZ Sródmiescie Sp z o.o.
Gdynia, Pomeranian Voivodeship, 81-394, Poland
Pomorskie Centra Kardiologiczne S.A.
Gdansk, 80126, Poland
S.P. Specjalistyczny Szpital Zachodni im.JP II
Grodzisk Mazowiecki, 05-825, Poland
Krakowski Szpital Specjalistyczny im.JPII
Krakow, 31-202, Poland
Synexus SCM Sp. z o.o. Oddział w Warszawie
Warsaw, 01-192, Poland
Centrum Badawcze Współczenej Terapii
Warsaw, 02-679, Poland
Slaskie Centrum Chorób Serca w Zabrzu
Zabrze, 41-800, Poland
MULTI-MED PLUS Sp. z o.o.
Lódz, Łódź Voivodeship, 90-553, Poland
Niepubliczny Zakład Opieki Zdrowotnej Przychodnia Zdrowia "Zadębie"
Skierniewice, Łódź Voivodeship, 96-100, Poland
City Hospital #38 named after Semashko N.A
Pushkin, Sankt-Peterburg, 196601, Russia
Altay Regional Cardiologycal Dispensary
Barnaul, 656055, Russia
"Chita State Medical Academy" Curative-Diagnostic Clinic department
Chita, 672039, Russia
Municipal Institution of Healthcare "Kemerovo Cardiology Dispensary"
Kemerovo, 650002, Russia
Non-state Institution of healthcare "Department hospital on station Kemerovo of OAO "Russian Railway"
Kemerovo, 650056, Russia
Medical centre "Delis", LLC
Kirovsk, 187342, Russia
Federal State Institution "National Research Center for Preventive Medicine"
Moscow, 101990, Russia
State healthcare institution of Moscow "City Clinical hospital#15 named after O.M.Filatov"
Moscow, 111539, Russia
State Healthcare institution of Moscow"Cardiology Dispensary #2"
Moscow, 117556, Russia
First Moscow State Medical University I.M. Sechenov
Moscow, 119991, Russia
State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
Moscow, 119991, Russia
State Budget Educational Institution of High Professional Education First Moscow State Medical University... #1, Cardiology Clinic, Hospital Therapy Department
Moscow, 119992, Russia
Moscow City Clinical Hospital #51
Moscow, 121309, Russia
FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
Moscow, 121359, Russia
Moscow State University of Medicine and Dentistry based on Moscow City Clinical Hospital #71
Moscow, 121374, Russia
City Clinical Hospital named after S.P.Botkin
Moscow, 125284, Russia
State Institution of Moscow Healthcare "City Clinical Hospital named after S.P. Botkin"
Moscow, 125284, Russia
Moscow State Institution of Health "City Clinical Hospital #81"
Moscow, 127644, Russia
Federal State Institution "Outpatient department #3" of President Management department of Russian Federation
Moscow, 129090, Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087, Russia
Regional Clinical Hospital named after N.N.Burdenko
Penza, 440026, Russia
State Institution of Healthcare Perm Regional Hospital for War Veterans
Perm, 614097, Russia
State Healthcare Institution "Ryazan regional clinical cardiological dispensary"
Ryazan, 390026, Russia
FGU Central Clinical Hospital with Polyclinic of President Administrative Department of RF
Saint Petersburg, 121359, Russia
Federal State Educational Institution of High Professional Education "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of Russia
Saint Petersburg, 191124, Russia
International Medical Center "SOGAZ", LLC
Saint Petersburg, 191186, Russia
State Healthcare institution "Municipal Out-patient Clinic #109"
Saint Petersburg, 192288, Russia
Saint-Petersburg State Healthcare Institution
Saint Petersburg, 193144, Russia
Federal Heart, Blood and Endocrinology Centre n.a. Almazov
Saint Petersburg, 194156, Russia
Institution and Address: "Medical Research Institute", LLC
Saint Petersburg, 196084, Russia
Federal Heart, Blood and Endocrinology Centre n.a. Almazov
Saint Petersburg, 197341, Russia
State Institution of Healthcare "City Hospital #40 of Kurortniy administrative district
Saint Petersburg, 197705, Russia
"Clinical hospital named after S.R.Mirotvortsev"
Saratov, 410054, Russia
Educational Institution of Higher Vocational Education "Smolensk State Medical Academy" on the base of Municipal Medicoprophylactic Institution "Hospital of Emergency Medical Care",
Smolensk, 214000, Russia
Autonomous healthcare institution of Voronezh region "Voronezh regional clinic consultative and diagnostic centre"
Voronezh, 394018, Russia
Municipal Institution of Healthcare "Clinical Hospital #8 of Yaroslavl"
Yaroslavl, 150030, Russia
Sverdlovsky Regional Clinical Hospital of Wars Veterans
Yekaterinburg, 620905, Russia
Cardiology Clinic, Clinical Center Serbia
Belgrade, 11000, Serbia
Institute of Cardiovascular Diseases
Kamenitz, 21204, Serbia
ALIAN, s.r.o.
Bardejov, 085 01, Slovakia
Cardioconsult, s.r.o.
Bratislava, 811 04, Slovakia
Kardiovaskulárne centrum, s.r.o.
Bratislava, 831 01, Slovakia
CARDIO D&R, s.r.o.
Košice, 040 22, Slovakia
KARDIOMED, s.r.o.
Lučenec, 984 01, Slovakia
Kardiocentrum Nitra, s.r.o.
Nitra, 949 01, Slovakia
University Clinic of Respiratory and Allergic Diseases Golnik
Golnik, 4204, Slovenia
University Klinicni Center Ljubljana
Ljubljana, 1000, Slovenia
General Hospital Murska Sobota
Murska Sobota, 9001, Slovenia
Donetsk National Medical University, Department of Internal Medicine #1 based on Department of Emergency Cardiology and Rehabilitation of Institute of Urgent and Recovery Surgery named after V. K. Gusak
Donetsk, 83045, Ukraine
Central Clinical Hospital of Ukrzaliznitsia, Cardiology department
Kharkiv, 61103, Ukraine
Kharkiv Medical Academy of Postgraduate Education, Department of cardiology and functional diagnostics based on City Clinical Hospital #8, Department of Cardiology #2
Kharkiv, 61176, Ukraine
Central polyclinic of Pechersk district, Department of cardiology
Kyiv, 01103, Ukraine
Kyiv City Clinical Hospital #1, Department of Emergency Cardiology
Kyiv, 02091, Ukraine
Kyiv city clinical hospital #5
Kyiv, 03115, Ukraine
Department of Diabetology of National Medical Academy of Postgraduate Education named after P.L.Shupyk based on Day Time Hospital of Administration of Medical Service and Rehabilitation of "ARTEM" SHC
Kyiv, 04050, Ukraine
SI "Institute of Gerontology of AMS of Ukraine"
Kyiv, 04114, Ukraine
Lviv National Medical University named after Danylo Halytsky, Department of Propaedeutics of Internal Medicine #1 based on Polyclinic Department of Municipal City Clinical Hospital #5
Lviv, 79044, Ukraine
SI Odessa Regional Cardiological Dispensary
Odesa, 65025, Ukraine
Related Publications (3)
Arnold SV, Kosiborod M, Li Y, Jones PG, Yue P, Belardinelli L, Spertus JA. Comparison of the Seattle Angina Questionnaire With Daily Angina Diary in the TERISA Clinical Trial. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):844-50. doi: 10.1161/CIRCOUTCOMES.113.000752. Epub 2014 Sep 23.
PMID: 25249560DERIVEDRoubinian NH, Escobar GJ, Liu V, Gardner MN, Carson JL, Kleinman SH, Murphy EL; NHLBI Recipient Epidemiology and Donor Evaluation Study (REDS-III). Decreased red blood cell use and mortality in hospitalized patients. JAMA Intern Med. 2014 Aug;174(8):1405-7. doi: 10.1001/jamainternmed.2014.2889. No abstract available.
PMID: 24978650DERIVEDKosiborod M, Arnold SV, Spertus JA, McGuire DK, Li Y, Yue P, Ben-Yehuda O, Katz A, Jones PG, Olmsted A, Belardinelli L, Chaitman BR. Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). J Am Coll Cardiol. 2013 May 21;61(20):2038-45. doi: 10.1016/j.jacc.2013.02.011. Epub 2013 Mar 10.
PMID: 23500237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Patrick Yue, MD
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 30, 2011
Study Start
September 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 4, 2014
Results First Posted
November 4, 2014
Record last verified: 2014-10