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Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB)

4 de agosto de 2019 actualizado por: Qiang Zhao,MD, Ruijin Hospital

Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this open-label study. All the enrolled patients will stop oral antiplatelet drugs according to local protocol before the surgery. Within the first 24 hours after surgery, study medication should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients will undergo a multislice computed tomography angiography to assess vein graft patency.

This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency.

Descripción general del estudio

Descripción detallada

The study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency. The primary comparison includes two separate parts. One is to demonstrate T+A better than A and the other is T better than A.

One year rate of vein graft patency in the aspirin group is estimated as 80%. The assumed rate of ticagrelor plus aspirin is 90%. With a two-sided alpha level 0.05 and 80% power, 199 grafts to each group are required. On the other hand, if we assume the rate of ticagrelor monotherapy has the 1-year vein graft patency rate of 87%, under the same two-sided 0.05 alpha 441 grafts in each arm will offer 80% power to show the superiority of ticagrelor along for the primary efficacy end point.

Combined the above two assumptions, if the allocation rate is 1:1:1, this study needs to recruit 1,323 grafts in total (441 in each) to achieve the pre-specified power for both the two comparisons (T+A vs. A and T vs. A).

The principle investigator assumes that the average number of the vien grafts in one patient is 2.7-3.0. With this assumption, 500 patients are to be recruited, which will provide us a total of 1350 - 1500 grafts.

According to the above, this study will be a confirmatory clinical trial to the primary endpoint.

Tipo de estudio

Intervencionista

Inscripción (Actual)

500

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Henan
      • Zhengzhou, Henan, Porcelana
        • Henan Provincial People's Hospital
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, Porcelana
        • Nan Jing First Hospital
    • Shanghai
      • Shanghai, Shanghai, Porcelana, 200433
        • Changhai Hospital of Shanghai
      • Shanghai, Shanghai, Porcelana, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, Porcelana, 200092
        • Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients able to provide written informed consent
  • Provision of informed consent prior to any study specific procedures
  • Female and male patients aged 18-80 years
  • Indication for CABG surgery

Exclusion Criteria:

  • Cardiogenic shock, haemodynamic instability
  • Need for urgent revascularization within 5 days from presentation
  • Single vessel disease
  • Two vessel disease with normal left ventricular function (> 50%)
  • Need for concomitant other cardiac surgery (e.g. valve replacement)
  • Need for dual antiplatelet treatment for the patients undergoing CABG after acute coronary syndrome(ACS)
  • Contraindication for aspirin and ticagrelor use(e.g. known allergy)
  • History of bleeding diathesis within 3 months prior presentation
  • History of significant GI bleed within 1 year prior presentation
  • History of peptic ulcer without GI bleeding in past 3 years
  • History of intracranial hemorrhage
  • History of moderate to severe liver impairment
  • Patient requires dialysis
  • Patient with an increased risk of bradycardic events (as patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree arteriolar-venular block or bradycardic-related syncope)
  • Need vitamin K antagonist therapy after bypass surgery eg. persistent atrial fibrillation, mechanical valves
  • Known, clinically important thrombocytopenia(i.e. < 100*109/L)
  • Known, clinically important anaemia (i.e. <100g/L)
  • Participation in another investigational drug or device study in the last 30 days
  • Pregnancy or lactation(for premenopausal women 2 methods of reliable contraception, one of which must barrier method, are required)
  • Concomitant oral or intravenous therapy with strong cytochrome P450 3A4(CYP3A4) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers which cannot be stopped for the course of the study (strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, over 1 litre daily of grapefruit juice. Substrates with narrow therapeutic index: cyclosporine, quinidine. Strong inducers: rifampin, phenytoin, carbamazepine. )
  • Any other condition such as active cancer
  • Life expectancy less than 12 months that may result in protocol non-compliance or a risk for being lost to follow up
  • Indication for major surgery(e.g. cancer treatment, carotid surgery, cerebral surgery, major vascular surgery)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Aspirin
aspirin 100mg tablet by mouth daily for 12 months
Experimental: Ticagrelor plus Aspirin
ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months
Experimental: Ticagrelor
ticagrelor 90mg tablet by mouth twice daily for 12 months

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Patency of Saphenous Vein Grafts
Periodo de tiempo: up to 12 months
assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis <50%) is defined as "patency".
up to 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Patency of Saphenous Vein Grafts
Periodo de tiempo: up to 7 days
assessed by MSCTA or CAG. FitzGibbon grade A (stenosis <50%) is defined as "patency".
up to 7 days
The Rate of Post-operative Atrial Fibrillation After CABG.
Periodo de tiempo: up to 7 days
Number of Participants with Post-operative Atrial Fibrillation after CABG
up to 7 days
The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification
Periodo de tiempo: up to 12 months
Number of Participants Free of Angina per CCS Classification
up to 12 months
The Number of Major Adverse Cardiovascular Event (MACE)
Periodo de tiempo: up to 12 months
MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology)
up to 12 months
Number of the Major Bleeding Events
Periodo de tiempo: up to 12 months
According to modified TIMI criteria, the "Major Bleeding Events" is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding).
up to 12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
The Rate of Gastroduodenal Injury Assessed by Esophagogastroduodenoscopy (EGD)
Periodo de tiempo: at 12 months
Not all but the patients recruited in Ruijin Hospital
at 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Qiang Zhao, MD.PhD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • Director de estudio: Yunpeng Zhu, MD., Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2014

Finalización primaria (Actual)

1 de enero de 2017

Finalización del estudio (Actual)

1 de enero de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de julio de 2014

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2014

Publicado por primera vez (Estimar)

28 de julio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Bypass de la arteria coronaria

Ensayos clínicos sobre Ticagrelor

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