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Clinical Trial Details

Trial ID: L4859
Source ID: NCT02586155
Associated Drug: Apabetalone
Title: Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
Acronym: BETonMACE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02586155/results
Conditions: Diabetes Mellitus, Type 2|Coronary Artery Disease
Interventions: DRUG: Apabetalone|DRUG: Placebo|DRUG: Atorvastatin|DRUG: Rosuvastatin
Outcome Measures: Primary: Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE, Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted., 120 weeks | Secondary: Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE, First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted., 120 weeks|Incidence of Hospitalization for Congestive Heart Failure (CHF), 120 weeks|Incidence of All-cause Mortality, 120 weeks|Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups, 120 weeks|Change in Glucose From Baseline Over Time Between and Within Treatment Groups, 120 weeks|Change in Alkaline Phosphatase (ALP) From Baseline Over Time Within and Between Treatment Groups, 172 weeks|Change in C Reactive Protein (CRP) Concentration From Baseline Over Time Within and Between Treatment Groups, 52 weeks|Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline Over Time Within and Between Treatment Groups for Subjects With Impaired Renal Function at Baseline (eGFR <60 mL/Min/1.7m2), 120 weeks
Sponsor/Collaborators: Sponsor: Resverlogix Corp | Collaborators: PPD DEVELOPMENT, LP|ICON plc|Medidata Solutions
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2425
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2015-11
Completion Date: 2021-06-21
Results First Posted: 2021-08-20
Last Update Posted: 2021-08-20
Locations: Instituto de Investigaciones Clinicas Bahia Blanca, Bahía Blanca, Argentina|Bioclinica Buenos Aires, Buenos Aires, Argentina|Centro Privado de Enfermedades Cardiovasculares, Buenos Aires, Argentina|Consultorios Asociados Endocronología E Investigación Clínica Aplicada, Buenos Aires, Argentina|Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina|Sanatorio Guemes, Buenos Aires, Argentina|Clinica Coronel Suarez, Coronel Suárez, Argentina|Instituto de Cardiologia de Corrientes Juana Francisca Cabral, Corrientes, Argentina|CEMAIC, Córdoba, Argentina|Centro Médico Colón, Córdoba, Argentina|Centro Médico Luquez, Córdoba, Argentina|Clínica Privada Del Prado Sociedad de Responsabilidad Limitada, Córdoba, Argentina|Fundación Clínica Colombo, Córdoba, Argentina|Hospital Cordoba, Córdoba, Argentina|Hospital San Roque, Córdoba, Argentina|Instituto Del Corazón, Córdoba, Argentina|Instituto Modelo de Cardiologia, Córdoba, Argentina|Instituto Médico DAMIC, Córdoba, Argentina|Ipac Caraffa, Córdoba, Argentina|Sanatorio Allende, Córdoba, Argentina|Centro Médico Libertad, Haedo, Argentina|CIMEL, Lanús, Argentina|Instituto de Investigaciones Clínicas Mar Del Plata, Mar Del Plata, Argentina|Hospital Central, Mendoza, Argentina|DIM Clinica Privada, Ramos Mejia, Argentina|Instituto de Hematologia Y Medicina Clinica, Rosario, Argentina|Sanatorio Britanico de Rosario, Rosario, Argentina|Prevencion Cardio Vascular, Salta, Argentina|Grupo Medico Alem, San Isidro, Argentina|Bioclinica Tucumán, San Miguel De Tucumán, Argentina|Centro Modelo de Cardiologia, San Miguel De Tucumán, Argentina|Investigaciones Clinicas Tucuman, San Miguel De Tucumán, Argentina|Centro de Investigaciones Clínicas Del Litoral SRL, Santa Fe, Argentina|Sanatorio San Francisco, Santiago Del Estero, Argentina|Clínica FUSAVIM Privada, Villa María, Argentina|Instituto de Investigaciones Clínicas Zárate, Zárate, Argentina|Flinders Medical Centre, Bedford Park, Australia|ZNA Middelheim, Antwerpen, Belgium|Imelda VZW, Bonheiden, Belgium|AZ Turnhout, Turnhout, Belgium|Multiprofile Hospital For Active Treatment Dr Tota Venkova, Gabrovo, Bulgaria|Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD, Lovech, Bulgaria|Multiprofile Hospital For Active Treatment - Pazardzhik AD, Pazardzhik, Bulgaria|University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD, Pleven, Bulgaria|Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD, Smolyan, Bulgaria|Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia, Bulgaria|City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia, Bulgaria|Medical Center Kardiohelp EOOD, Sofia, Bulgaria|Second Multiprofile Hospital for Active Treatment Sofia, Sofia, Bulgaria|Synexus Affiliate - Diagnostic and Consulting Center Ascendent, Sofia, Bulgaria|University Multiprofile Hospital for Active Treatment Aleksandrovska EAD, Sofia, Bulgaria|University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD, Sofia, Bulgaria|Medical Center Orfey OOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Sveta Marina EAD, Varna, Bulgaria|General Hospital Karlovac, Karlovac, Croatia|Special Hospital for medicinal rehabilitation Krapinske Toplice, Krapinske Toplice, Croatia|Clinical Hospital Osijek, Osijek, Croatia|General Hospital Dr Josip Bencevic, Slavonski Brod, Croatia|General Hospital Virovitica, Virovitica, Croatia|Clinical Hospital Sveti duh, Zagreb, Croatia|DRK Kliniken Berlin Westend, Berlin, Germany|Medizinisches Versorgungszentrum am Küchwald GmbH, Chemnitz, Germany|Zentrum für Klinische Prüfung in der Facharztzentrum Dresden Neustadt Gbr, Dresden, Germany|Katholisches Krankenhaus St. Johann Nepomuk, Erfurt, Germany|Heidelberger Praxisklinik für Kardiologie, Heidelberg, Germany|Klinikum Hoyerswerda, Hoyerswerda, Germany|Studienzentrum Dr.Appel, Kassel, Germany|Asklepios Klinik Langen, Langen, Germany|Klinikum Leverkusen GmbH, Leverkusen, Germany|Bajai Szent Rókus Kórház, Baja, Hungary|Grof Tisza Istvan Korhaz Berettyoujfalu, Berettyóújfalu, Hungary|Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest, Hungary|Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet, Budapest, Hungary|Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Budapest, Hungary|Magyar Honvédség Egészségügyi Központ, Budapest, Hungary|Semmelweis Egyetem, Budapest, Hungary|Synexus (DRS) - Synexus Magyarország Kft. Budapest, Budapest, Hungary|Szent Margit Korhaz, Budapest, Hungary|Szent Rókus Kórház és Intézményei, Budapest, Hungary|Selye János Kórház, Komárom, Hungary|TaNaMed Kft., Mosonmagyaróvár, Hungary|Kanizsai Dorottya Kórház, Nagykanizsa, Hungary|Coromed-SMO Kft., Pécs, Hungary|Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, Hungary|Tolna Megyei Balassa János Kórház, Szekszárd, Hungary|Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár, Hungary|Barzilai Medical Center, Ashkelon, Israel|Soroka University Medical Centre, Be'er Sheva, Israel|Hillel Yaffe Medical Center, Hadera, Israel|Bnei Zion Medical Center, Haifa, Israel|Lady Davis Carmel Medical Center, Haifa, Israel|Linn Medical Center Clalit Health Services, Haifa, Israel|Rambam Medical Center, Haifa, Israel|Edith Wolfson Medical Center, Holon, Israel|Hadassah University Hospital Ein Kerem, Jerusalem, Israel|Hadassah University Hospital Mount Scopus, Jerusalem, Israel|Shaare Zedek Medical Center, Jerusalem, Israel|Meir Medical Center, Kefar-Sava, Israel|Galilee Medical Center, Nahariya, Israel|Nazareth EMMS Hospital, Nazareth, Israel|Chaim Sheba Medical Center, Ramat Gan, Israel|Kaplan Medical Center, Rehovot, Israel|ZIV Medical Center, Safed, Israel|Clalit Health Medical Center, Tel Aviv, Israel|Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel|Baruch Padeh Poriya Medical Center, Tiberias, Israel|Fundacion Cardiovascular de Aguascalientes AC, Aguascalientes, Mexico|Hospital Cardiológica Aguascalientes, Aguascalientes, Mexico|Investigacion en Salud y Metabolismo S.C., Chihuahua, Mexico|Centro de Investigación Biomedica y Farmaceutica, Ciudad de México, Mexico|Clinica Integral del Paciente Diabetico y Obeso, Ciudad De México, Mexico|Fundación de Atención e Investigación Médica Lindavista S.C., Ciudad de México, Mexico|Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC, Culiacan, Mexico|Centro de Investigacion y Atencion de Diabetes, Endocrinologia y Nutricion, Durango, Mexico|Arechavaleta Granell Maria del Rosario, Guadalajara, Mexico|Centro de Investigacion Medica Biologica Y de Terapia Avanzada SC, Guadalajara, Mexico|Unidad de Investigacion Clinica Cardiometabolica de Occidente SC, Guadalajara, Mexico|Hospital Angeles Leon, León De Los Aldama, Mexico|Centro de Desarrollo Biomédico, Merida, Mexico|Sanatorio y Servicios Médicos Obregón S.A. de C.V., Mexico City, Mexico|Instituto Cardiovascular de Monclova, Monclova, Mexico|Hospital Universitario Dr. Jose Eleuterio González, Monterrey, Mexico|IMED Internal Medicine Clin Trials, Monterrey, Mexico|Unidad de Investigación Clínica En Medicina SC, Monterrey, Mexico|Diabetes Total, S.A de C.V., Pachuca, Mexico|Investigacion Biomedica Aplicada de Hidalgo S.A. de C.V., Pachuca, Mexico|Cardioarritmias e Investigación S.C., San Luis Potosi, Mexico|Hospital Central Dr Ignacio Morones Prieto, San Luis Potosí, Mexico|INBIOMEDYC Toluca, Toluca, Mexico|Centro de Alta Especialidad Dr. Rafael Lucio, Veracruz, Mexico|Dr. Humberto Alvarez Lopez, Zapopan, Mexico|Meander Medisch Centrum, Amersfoort, Netherlands|OLVG locatie Oost, Amsterdam, Netherlands|VU Medisch Centrum, Amsterdam, Netherlands|Podlaski Osrodek Kardiologii Poradnia Prywatna, Bialystok, Poland|Malopolskie Centrum Sercowo-Naczyniowe, Chrzanow, Poland|Polsko-Amerykanskie Kliniki Serca, Dabrowa Gornicza, Poland|Gabinet Kardiologiczno-Internistyczny, Gdynia, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Centrum Uslug Medycznych Promont-Med., Kielce, Poland|Diamond Clinic, Kraków, Poland|Szpital Specjalistyczny im. Jozefa Dietla w Krakowie, Kraków, Poland|Zespol Przychodni Specjalistycznych DIAB-END-COR Sp. z o.o., Kraków, Poland|Prywatna Praktyka Lekarska MAZ-MEDICA Maciej R.Mazurkiewicz, Lodz, Poland|Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow, Lódz, Poland|Polsko-Amerykanskie Kliniki Serca, Nysa, Poland|Pro Corde, Dom Medyczny, Opole, Poland|Medicome Sp. z o.o., Oswiecim, Poland|Rodzinne Centrum Zdrowia, Otwock, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska "MEDIKARD", Plock, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne SBB, Tarnobrzeg, Poland|Centrum Medyczne doktorA, Warszawa, Poland|Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Warszawa, Poland|Niepubliczny Zaklad Opieki Zdrowotnej AURUM, Warszawa, Poland|Centrum Kardiologiczne Pro Corde Sp. z o.o. Niepubliczny Zaklad Opieki Zdrowotnej, Wroclaw, Poland|Wro Medica, Wroclaw, Poland|City Clinical Hospital #6, Chelyabinsk, Russian Federation|Ural State Medical University, Ekaterinburg, Russian Federation|Federal Budget Healthcare Institution Medici - sanitary unit of Ministry of internal affairs of Russ, Kemerovo, Russian Federation|Research Institute of Complex Cardiovascular Pathology, Kemerovo, Russian Federation|Krasnodar Regional Clinical Hospital #2, Krasnodar, Russian Federation|Moscow City State Budgetary Healthcare Institution City Clinical Hospital named after V.V. Veresayev, Moscow, Russian Federation|Russian Cardiology Research and Production Center, Moscow, Russian Federation|City Hospital 13, Nizhniy Novgorod, Russian Federation|State Budgetary Healthcare Institution of Novosibirsk Region City Clinical Hospital No. 19, Novosibirsk, Russian Federation|Republican Hospital n.a. V.A. Baranov, Petrozavodsk, Russian Federation|Municipal Budgetary Healthcare Institution City Emergency Hospital, Rostov-on-Don, Russian Federation|International Medical Center SOGAZ, Saint Petersburg, Russian Federation|North-West State Medical University n.a. I.I. Mechnikov, Saint Petersburg, Russian Federation|St Petersburg City Outpatient Clinic #109, Saint Petersburg, Russian Federation|Saratov State Medical University, Saratov, Russian Federation|State Healthcare Institution Regional Clinical Cardiologic Dispensary, Saratov, Russian Federation|City Hospital #4, Sochi, Russian Federation|Research Cardiology Institute of Tomsk Scientific Center of RAMS Siberian Branch, Tomsk, Russian Federation|State Budgetary Healthcare Institution of Vladimir Region City Hospital No. 4, Vladimir, Russian Federation|Clinical Center of Serbia, Belgrade, Serbia|Clinical Hospital Centar Zvezdara, Belgrade, Serbia|Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia|Clinical Hospital Centre Zemun, Belgrade, Serbia|Euromedik, Belgrade, Serbia|Institute of Cardiovascular Diseases Dedinje, Belgrade, Serbia|KBC Dr Dragisa Misovic Dedinje, Belgrade, Serbia|Military Medical Academy, Belgrade, Serbia|Clinical Center Kragujevac, Kragujevac, Serbia|Institute Niska Banja, Niska Banja, Serbia|Clinical Center Nis, Nis, Serbia|Clinical Centre of Vojvodina, Novi Sad, Serbia|Institute of Cardiovascular Diseases of Vojvodina, Sremska Kamenica, Serbia|General Hospital Uzice, Uzice, Serbia|Health Center Zajecar, Zajecar, Serbia|ALIAN, s.r.o, Bardejov, Slovakia|CARDIOCONSULT, s.r.o., Bratislava, Slovakia|Univerzitna nemocnica Bratislava, Bratislava, Slovakia|Kardio-Onkologia, s.r.o., Dolny Kubin, Slovakia|CARDIO D&R, s.r.o. Kosice, Kosice, Slovakia|Zeleznicne zdravotnictvo Kosice, s.r.o., Kosice, Slovakia|KARDIOMED s.r.o., Lucenec, Slovakia|MEDI M&M s.r.o., Moldava nad Bodvou, Slovakia|Nemocnica s poliklinikou Nove Mesto nad Vahom n.o., Nove Mesto nad Vahom, Slovakia|Cardioinvest s. r. o., Nove Zamky, Slovakia|DIAB s.r.o., Roznava, Slovakia|MEDIVASA, s.r.o., Zilina, Slovakia|Changhua Christian Hospital, Changhua, Taiwan|Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan|Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan|Mackay Memorial Hospital-Taipei branch, New Taipei City, Taiwan|China Medical University Hospital, Taichung, Taiwan|National Cheng Kung University Hospital, Tainan City, Taiwan|Tri-Service General Hospital, Taipei City, Taiwan|Cathay General Hospital, Taipei, Taiwan|Chi Mei Medical Center, Taipei, Taiwan|Far Eastern Memorial Hospital, Taipei, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Taipei Veterans General Hospital, Taipei, Taiwan|Chang Gung Medical Foundation Linkou Branch (Clinical Research Center), Taoyuan City, Taiwan
URL: https://clinicaltrials.gov/show/NCT02586155

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress