1. Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study
- Author
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Bhatt, Deepak L., Fox, Kim, Harrington, Robert A., Leiter, Lawrence A., Mehta, Shamir R., Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Ridderstrale, Wilhelm, Held, Claes, Steg, Philippe Gabriel, Steg, Gabriel, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter, Nicolau, Jose Carlos, Kerr Saraiva, Jose Francisco, Petrov, Ivo, Corbalan, Ramon, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimsky, Petr, Kristensen, Steen Dalby, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Fat, Tse Hung, Kiss, Robert Gabor, Pais, Prem, Lev, Eli, De Luca, Leonardo, Goto, Shinya, Ramos Lopez, Gabriel Arturo, Cornel, Jan Hein, Kontny, Frederic, Medina, Felix, Babilonia, Noe, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry, Ruda, Mikhail, Elamin, Omer, Kovar, Frantisek, Dalby, Anthony John, Jeong, Myung Ho, Bueno, Hector, James, Stefan, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik, Parkhomenko, Alexander, McGuire, Darren, Kosiborod, Mikhail, Nguyen, Tuan Quang, Wallentin, Lars, Fox, Keith A. A., Eikelboom, John W., Tuomilehto, Jaakko, Lee, Kerry L., Al-Khalidi, Hussein R., Ellis, Stephen J., Hagström, Emil, Holmgren, Pernilla, Heldestad, Ulrika, Hallberg, Theresa, Renlund Grausne, Karin, Alm, Cristina, Michelgård Palmquist, Åsa, Svanberg, Camilla, Capell, Warren H., Nehler, Mark R., Hiatt, William R., Bonaca, Marc P., Houser, Stacey, Bachler, Susie, Jaeger, Nicole, Aunes, Maria, Brusehed, Asa, Chen, Jersey, Dahlof, Bjorn, Dolezalova, Jitka, Domzol, Maciej, Findley, Magdalena, Holmberg, Niclas, Jahreskog, Marianne, Knutsson, Mikael, Kruszewski, Jakub, Leonsson-Zachrisson, Maria, Stark, Maj, Winder, Elin, and Sinnaeve, P
- Subjects
Male ,Ticagrelor ,Cardiac & Cardiovascular Systems ,Time Factors ,medicine.medical_treatment ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Myocardial Infarction ,general clinical cardiology/adult ,Coronary Artery Disease ,Type 2 diabetes ,030204 cardiovascular system & hematology ,Stroke/mortality ,antiplatelet therapy ,Hypoglycemic Agents/adverse effects ,Coronary artery disease ,DOUBLE-BLIND ,0302 clinical medicine ,Risk Factors ,ARTERY-DISEASE ,Medicine ,Cardiac and Cardiovascular Systems ,030212 general & internal medicine ,Myocardial infarction ,1102 Cardiorespiratory Medicine and Haematology ,Stroke ,Randomized Controlled Trials as Topic ,Aspirin ,Kardiologi ,adult ,general clinical cardiology ,60 MG ,Ticagrelor/administration & dosage ,General Medicine ,Middle Aged ,Clopidogrel ,Treatment Outcome ,CLOPIDOGREL ,diabetes mellitus ,Cardiology ,PLATELET INHIBITION ,Drug Therapy, Combination ,Female ,Cardiology and Cardiovascular Medicine ,Life Sciences & Biomedicine ,medicine.drug ,medicine.medical_specialty ,Trial Designs ,03 medical and health sciences ,Diabetes Mellitus, Type 2/diagnosis ,Double-Blind Method ,Internal medicine ,Humans ,Hypoglycemic Agents ,CARDIOVASCULAR EVENTS ,Aspirin/administration & dosage ,Myocardial Infarction/mortality ,Platelet Aggregation Inhibitors/administration & dosage ,Aged ,clinical trials ,Science & Technology ,business.industry ,ACUTE CORONARY SYNDROMES ,Percutaneous coronary intervention ,medicine.disease ,ischemic heart disease ,ASPIRIN ,MYOCARDIAL-INFARCTION ,Cardiovascular System & Hematology ,Clinical Trials, Phase III as Topic ,Diabetes Mellitus, Type 2 ,Cardiovascular System & Cardiology ,Coronary Artery Disease/diagnosis ,business ,THEMIS Steering Committee ,Platelet Aggregation Inhibitors - Abstract
In the setting of prior myocardial infarction, the oral antiplatelet ticagrelor added to aspirin reduced the risk of recurrent ischemic events, especially, in those with diabetes mellitus. Patients with stable coronary disease and diabetes are also at elevated risk and might benefit from dual antiplatelet therapy. The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS, NCT01991795) is a Phase 3b randomized, double-blinded, placebo-controlled trial of ticagrelor vs placebo, on top of low dose aspirin. Patients ≥50 years with type 2 diabetes receiving anti-diabetic medications for at least 6 months with stable coronary artery disease as determined by a history of previous percutaneous coronary intervention, bypass grafting, or angiographic stenosis of ≥50% of at least one coronary artery were enrolled. Patients with known prior myocardial infarction (MI) or stroke were excluded. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint is Thrombolysis in Myocardial Infarction major bleeding. A total of 19 220 patients worldwide have been randomized and at least 1385 adjudicated primary efficacy endpoint events are expected to be available for analysis, with an expected average follow-up of 40 months (maximum 58 months). Most of the exposure is on a 60 mg twice daily dose, as the dose was lowered from 90 mg twice daily partway into the study. The results may revise the boundaries of efficacy for dual antiplatelet therapy and whether it has a role outside acute coronary syndromes, prior myocardial infarction, or percutaneous coronary intervention. ispartof: CLINICAL CARDIOLOGY vol:42 issue:5 pages:498-505 ispartof: location:United States status: published
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- 2019