Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness ADOPT

Not Applicable

• Conditions: -I809 Phlebitis and thrombophlebitis of unspecified site; Phlebitis and thrombophlebitis of unspecified site; I809

• Registration Number: PER-119-08
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 112

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

• 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 <30 ml / min estimated using the Cockcroft and Gault method (see Section 6.3.1.2)
• Hospitalized patients more than 48 hours before randomization
• Patients who are not in a position to take oral medications
• Patients who in the last 30 days have undergone surgery that may be associated with a risk of bleeding
• Patients who in the last 14 days have received treatment for consecutive days consisting of: more than two doses of enoxaparin or another low molecular weight heparin; more than two doses of fondaparin; more than four doses of unfractionated heparin; an infusion of unfractionated heparin for more than 48 hours; or more than two doses of an oral anticoagulant.
• Patients with active bleeding or high risk of bleeding
• Patients who have invasive procedures scheduled during the treatment period
• Patients in whom, in the opinion of the Researcher, it is not possible to obtain an adequate evaluation by means of bilateral ultrasound with compression
• Patients with acute shock
• Patients with a life expectancy <1 month
• Abnormal hematological findings: Hemoglobin <9 g / dl, Platelet count <100,000 / mm3
• Abnormal liver function tests: ALT or AST> 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified