- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01852162
Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy
Pharmacodynamic Effects of Dabigatran in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in particular atrial fibrillation, therefore having an indication to also receive oral anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under "triple therapy" which consists of aspirin plus clopidogrel plus an oral anticoagulant. Although this combination therapy allows a reduction of atherothrombotic and thromboembolic events, patients on triple therapy are at an increased risk of bleeding complications.
Dabigatran, a synthetic, reversible direct thrombin inhibitor, has been studied as an alternative to warfarin in patients with atrial fibrillation and has been shown to be at least as efficacious with a favorable safety profile. In particular, dabigatran at a dose of 110 mg is associated with rates of stroke and systemic embolism similar to warfarin, with lower rates of major hemorrhage, while a dose of 150 mg is associated with lower thrombotic events with similar rates of bleeding events. These findings have led the Food and Drug Administration (FDA) to approve dabigatran for use in atrial fibrillation patients in December 2011 and this has also been implemented in practice guidelines to be a superior strategy to warfarin. However, the FDA only approved the 150mg formulation.
Dabigatran has high affinity and specificity for its target serine protease thrombin, and one small study shows that dabigatran produced potent inhibition of thrombin-induced platelet aggregation in vitro. However, there are no studies assessing the ex vivo pharmacodynamic effects of dabigatran in patients on dual antiplatelet therapy. The ever raising population with CAD warranting triple therapy and the growing number of patients being treated with dabigatran underscores the importance of understanding the pharmacodynamic effects of this treatment regimen.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
- University of Florida
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with known CAD
- On maintenance treatment with aspirin (81 to 325mg per day) and clopidogrel (75 mg per day) for at least for at least 4-weeks as per standard of care.
- Age between 18 and 80 years old.
Exclusion Criteria:
- Transient ischemic attack or ischemic stroke in the past 6 months.
- Prior hemorrhagic stroke (irrespective of timing).
- Known allergies to dabigatran.
- On treatment with Coumadin derivate or have an indication to be on Coumadin treatment (atrial fibrillation, prosthetic valve, DVT/pulmonary embolism).
- Platelet count <80x106/mL
- Active bleeding or hemodynamic instability.
- Creatinine clearance <30 mL/minute.
- Baseline ALT >2.5 times the upper limit of normal.
- Hemoglobin < 10 gm/dL
- Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
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Tabletas de placebo a juego
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Experimental: Dabigatran
Dabigatran 150mg
|
Dabigatran 150mg
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
TRAP-induced Platelet Aggregation
Periodo de tiempo: 1 week
|
TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups
|
1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Platelet Reactivity Measured by LTA
Periodo de tiempo: 1-week
|
Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).
|
1-week
|
Platelet Reactivity Measured by Multiple Electrode Aggregometry.
Periodo de tiempo: 1-week
|
Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.
|
1-week
|
Clot Kinetic: Thrombin Activity
Periodo de tiempo: 1-week
|
Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.
|
1-week
|
Clot Kinetic: Clot Stength
Periodo de tiempo: 1-week
|
Clot strength (maximal amplitude:MA) was assessed by thromboelastography.
|
1-week
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Antitrombinas
- Inhibidores de la serina proteinasa
- Anticoagulantes
- Dabigatrán
Otros números de identificación del estudio
- UFJ 2011-112
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