None listed
Conditions
Interventions
Group 1 Type of group
Apixaban oral 2.5 mg twice daily for 30 days
Group name:Group 2 Type of group
Subcutaneous Enoxaparin 40 mg once daily during hospitalization and for a minimum of 6 days
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Patients must be willing and able to give written informed consent. Consent to participate in the study must be obtained before selection. • Hospitalized patients due to congestive heart failure, acute respiratory failure or infection (without septic shock), acute rheumatic disease or inflammatory bowel disease. • Except for patients with congestive heart failure or respiratory failure, patients should have an additional factor, including: 1) age> 75 3) cancer 4) BMI> 30 (See Appendix 4 for the BMI Table) 5) estrogenic hormonal treatment 6) chronic heart or respiratory failure • Patients with planned hospitalization for> 3 days after randomization • Severe or moderate mobility restriction (ie: prostrate or limited to a chair, walk to the bathroom or into the room; see section 6.9.1) • Men and women of any race, at least 40 years of age
Exclusion criteria
Exclusion criteria: • MEF who do not wish or cannot use an acceptable method to prevent pregnancy during the entire study period. • MEF that use a prohibited contraceptive method • Pregnant or breastfeeding women • Women with a positive pregnancy test at enrollment or before administration of the product under investigation • Patients with confirmed VTE • Patients with diseases that require ongoing treatment with a parenteral or oral anticoagulant, eg, patients with mechanical valves, atrial fibrillation eligible for warfarin treatment • Patients with conditions that require ongoing treatment with parenteral antiplatelet agents or two or more oral antiplatelet agents • Active liver disease evidenced through abnormal laboratory test findings (see physical and laboratory findings below) • Anemia or thrombocytopenia evidenced by abnormal laboratory test findings (see physical and laboratory findings below) • Severe kidney disease evidenced by a creatinine clearance 2 X LSN or bilirubin (direct or total)> 1.5 x LSN (except when an alternative causative factor has been identified [eg, Gilbert´s syndrome]) • Known allergies or suspected enoxaparin allergy or previous thrombocytopenia induced by heparin • Treatment with bevacizumab (Avastin®) within the previous 6 months or scheduled use during the study period • Current treatment with oral anticoagulants • Current treatment with dual oral antiplatelet agents or aspirin in a dose> 165 mg. • Compulsory prisoners or institutionalized patients (involuntarily confined) may not be enrolled in this study for the treatment of a psychiatric or physical illness (eg an infectious disease). • Administration of any investigational medication currently or within 30 days prior to the scheduled enrollment of this study • Patients who are unwilling or unable to comply with the study medication instructions, including the use of enoxaparin • Patients who are unwilling or unable to comply with the study procedures (eg, bilateral compression ultrasound) specified in the protocol • Patients who have been previously randomized in an experimental study of apixaban
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants). Measure:Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants Timepoints:Day 1 to last dose of parenteral study drug plus 1 day ; Outcome name:Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Measure:Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period Timepoints:Intended Treatment Period ; Outcome name:Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: pe | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Measure:Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period Timepoints:Intended Treatment Period ; Outcome name:Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Measure:Incidence of Major Bleeding During the Treatment Period in Treated Participants Timepoints:Day 1, first dose of study drug, to last dose of study drug plus 2 days ; Outcome name:Bleeding was adjudicated by an ICAC using criteria from the ISTH. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Italy, Korea South, Malasya, Mexico, Netherlands, Norway, Palau, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Sweden, Taiwan, Turkey, Ukraine, United Kindgdom
Outcome results
None listed