A Multinational, Randomised, Double-Blind, Placebo-Contro... | EligiMed

A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study).

CompletadoFase 3ClinicalTrials.gov

ID: NCT01991795RENIS: IS000547Tipo: INTERVENTIONALInicio: 10 de feb de 2014Fin estimado: 25 de ene de 2019

Cardiología Neurología Endocrinología Hematología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

Descripción detallada

A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Criterios de exclusión

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis

Intervenciones

drug

Ticagrelor 60 mg

Ticagrelor 60 mg bd taken orally as tablets

drug

Ticagrelor placebo

Ticagrelor placebo bd taken orally as tablets

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Ciudad Autonomade Buenos Aires, Argentina

Research Site

Ciudad Autónoma de Bs. As., Argentina

Research Site

Ciudadela, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Ranelagh, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario, Argentina

Research Site

San Luis, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Nicolás, Argentina

Research Site

Santa Fe, Argentina

Research Site

Venado Tuerto, Argentina

Research Site

Villa María, Argentina

Patrocinadores

PrincipalAstraZeneca

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