Hemotrial Un proyecto de SEHH

Ensayo clínico

"Estudio BMS CV185030- Estudio fase III, controlado con Warfarina, aleatorizado, doble ciego y de brazos paralelos, para evaluar la seguridad y la eficacia de Apixaban en la prevención de accidente cerebrovascular y embolismo sistémico en pacientes con fibrilación auricular no valvular."A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006

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Resumen

2017-03-15 03:59:42
2006-002147-91
CV185-030
"Estudio BMS CV185030- Estudio fase III, controlado con Warfarina, aleatorizado, doble ciego y de brazos paralelos, para evaluar la seguridad y la eficacia de Apixaban en la prevención de accidente cerebrovascular y embolismo sistémico en pacientes con fibrilación auricular no valvular."A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006
ARISTOTLE
CV185-030

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Bristol Myers Squibb International Corporation Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Coumadin
Bristol-Myers Squibb Company Apixaban
BMS-562247 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-562247 (lab

Concentración del fármaco:
mg milligram(s) equal

2.5

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test
Apixaban
BMS-562247 Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS-562247 (lab

Concentración del fármaco:
mg milligram(s) equal

5

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Comparator
Coumadin
Tablet
Oral use

Detalles del Fármaco (Principio Activo):
BMS 565793

Concentración del fármaco:
mg milligram(s) equal

2

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Film-coated tablet

Oral use
  PLACEBO 2:

Si
Film-coated tablet

Oral use
  PLACEBO 3:

Si
Tablet

Oral use

Información General

Enfermedad Trombótica

ARRITMIA; TROMBOSISARRHYTHMIA; THROMBOSIS

To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in thecombined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, insubjects with AF and at least one additional risk factor for stroke.

• Determine in subjects with AF & at least 1 additional risk factor for stroke,whether apixaban is superior to warfarin in combined endpoints of: - ischemic stroke, hemorrhagic stroke & systemic embolism? ischemic stroke, hemorrhagic stroke, systemic embolism & major bleeding, in warfarin naïve subjects? ischemic stroke, hemorrhagic stroke, systemic embolism and major bleeding• To compare, in subjects with AF & at least 1 additional risk factor for stroke,apixaban and warfarin with respect to the composite endpoint of:- ischemic stroke, hemorrhagic stroke, systemic embolism & all cause death? ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding & all cause death? ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction & all cause death? incidence of major bleeding• To assess safety of apixaban in subjects with AF & at least 1 additional riskfactor for stroke.

No


For entry into the study, the following criteria MUST be met.1) Age >= 18 years2) Permanent or persistent atrial fibrillation or atrial flutter documented by ECG at thetime of enrollment.ORIf not in atrial fibrillation/flutter at the time of enrollment, must have atrialfibrillation/flutter documented on two separate occasions at least 2 weeks apart in the 6months prior to enrollment. Atrial fibrillation/flutter may be documented by ECG, or asan episode at least one minute in duration on a rhythm strip or Holter recording.3) One or more of the following risk factor(s) for stroke:a) Age 75 years or olderb) Prior stroke, TIA or systemic embolusc) Either symptomatic congestive heart failure within 3 months or left ventriculardysfunction with an LV ejection fraction (LVEF) =< 40% by echocardiography,radionuclide study or contrast angiographyd) Diabetes mellituse) Hypertension requiring pharmacological treatment4) Women of childbearing potential (WOCBP) must be using an adequate method ofcontraception to avoid pregnancy throughout the treatment period of the study or for2 weeks after the last dose of study medication, whichever is longer, in such a manner that the risk of pregnancy is minimized.WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oralcontraceptives, other hormonal contraceptives (vaginal products, skin patches, orimplanted or injectable products), or mechanical products such as an intrauterine deviceor barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or arepracticing abstinence or where their partner is sterile (eg, vasectomy) should beconsidered to be of childbearing potential.WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 48 hours prior to the start of investigationalproduct.5) All subjects must provide signed written informed consent.

1) Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)2) Clinically significant (moderate or severe) mitral stenosis3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation(e.g. documented peptic ulcer disease within 6 months, previous intracranialhemorrhage)4) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.prosthetic mechanical heart valve)5) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, or diastolic BP> 100 mm Hg)6) Active infective endocarditis7) Planned major surgery8) Planned atrial fibrillation or flutter ablation procedure9) Use of an unapproved, investigational drug or device within the past 30 days10) Required treatment with aspirin > 165 mg/day11) Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel,ticlopidine)12) Severe comorbid condition with life expectancy of =< 1 year13) Active alcohol or drug abuse, or psychosocial reasons that make study participationimpractical14) Recent stroke (within 30 days)15) Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinineclearance < 25 mL/min)16) ALT or AST > 2X ULN or a Total Bilirubin >= 1.5X ULN (unless an alternativecausative factor [e.g., Gilbert’s syndrome] is identified)17) Platelet count =< 100,000/ mm318) Hemoglobin < 10 g/dL19) Inability to comply with INR monitoring20) Prior randomization into an apixaban clinical study21) Prisoners or subjects who are involuntarily incarcerated22) Subjects who are compulsorily detained for treatment of either a psychiatric orphysical (e.g., infectious disease) illness23) Women of child bearing potential (WOCBP) unwilling or unable to use an acceptablemethod to avoid pregnancy:a) WOCBP using a prohibited contraceptive methodb) WOCBP include any female who has experienced menarche and who has notundergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12consecutive months; or women on hormone replacement therapy (HRT) withdocumented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. Evenwomen who are using oral contraceptives, other hormonal contraceptives (vaginalproducts, skin patches, or implanted or injectable products), or mechanicalproducts such as an intrauterine device or barrier methods (diaphragm, condoms,spermicides) to prevent pregnancy, or are practicing abstinence or where theirpartner is sterile (e.g., vasectomy) should be considered to be of child bearingpotentialc) Women who are pregnant or breastfeedingd) Women with a positive pregnancy test on enrollment or prior to administration ofinvestigational product.Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and the integrity of the study data. It is imperative that subjects fully meet all eligibility criteria.

Primary efficacy endpointThe primary efficacy endpoint will be the time to first occurrence of confirmed ischemic stroke, hemorrhagic or systemic embolism.The secondary efficacy endpoints will be time to first occurrence of confirmed:• ischemic stroke• hemorrhagic stroke• systemic embolism• all cause death• composite of ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding• composite of ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death• composite of ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, all cause death• composite of ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction, all cause deathPrimary safety endpointThe primary safety endpoint is the time to first occurrence of confirmed major bleeding.Secondary safety endpointsThe secondary safety outcome for this trial is a composite of confirmed major bleeding and confirmed clinically significant non-major bleeding. Other safety outcome measures will also be assessed, and will include minor bleeds, fractures and other AEs as well as abnormal standard clinical laboratory test results. All major bleeding and clinically relevant non-major bleeding outcomes will be adjudicated by CEC.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:

Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

3
5
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

516

Para estudios internacionales:

5010
15000

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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