A phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of venous thromboembolism in acutely III medical subjects during and following hospitalization. - ADOPT

Bristol Myers Squibb International Corporation0 sites7,502 target enrollmentJanuary 9, 2008

ConditionsTotal Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT MedDRA version: 9.1Level: LLTClassification code 10043566Term: Thromboembolism

DrugsCLEXANE

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Total Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT
Sponsor: Bristol Myers Squibb International Corporation
Enrollment: 7502
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 9, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Bristol Myers Squibb International Corporation

Eligibility Criteria

Inclusion Criteria

•1\) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to screening. 2\) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel disease. 3\) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including: a) age ≥ 75 b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks c) cancer d) BMI ≥ 30 (See Appendix 4 for BMI chart) e) estrogenic hormone therapy f) chronic heart or respiratory failure 4\) Expected hospitalization of ≥ 3 days after randomization 5\) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6\.9\.1\) 6\) Men and women, of any race, at least 40 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period 2\) WOCBP using a prohibited contraceptive method 3\) Women who are pregnant or breastfeeding 4\) Women with a positive pregnancy test on enrollment or prior to investigational product administration 5\) Subjects with a confirmed VTE 6\) Subjects with diseases requiring ongoing treatment with a parenteral or oral anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation 7\) Subjects with conditions requiring treatment with parenteral or oral antiplatelet agents other than aspirin ≤ 165 mg/day 8\) Active liver disease as evidenced by abnormal laboratory test findings (see physical and laboratory findings below) 9\) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings (see physical and laboratory findings below) 10\) Severe renal disease as evidenced by creatinine clearance \< 30 mL/min as estimated by the method of Cockcroft and Gault (see Section 6\.3\.1\.2\) 11\) Subjects hospitalized more than 48 hours prior to randomization 12\) Subjects who are unable to take oral medications 13\) Subjects who have had surgery in the past 30 days that may be associated with a risk of bleeding 14\) Subjects who have received anticoagulant prophylaxis for VTE in the past 14 days consisting of more than two doses of enoxaparin or another low molecular weight heparin, more than four doses of unfractionated heparin, or more than two doses of an oral anticoagulant 15\) Subjects with active bleeding or high risk of bleeding 16\) Subjects with planned or scheduled invasive procedures during the treatment period 17\) Subjects in whom in the opinion of the Investigator it is not possible to obtain an adequate bilateral compression ultrasound evaluation 18\) Subjects with acute shock 19\) Subjects with a life expectancy \< 1 month 20\) Abnormal hematological findings: Hemoglobin \< 10 g/dL Platelet count \< 100,000/mm 21\) Abnormal liver function tests: ALT or AST \> 2 X ULN or bilirubin (direct or total) \> 1\.5 X ULN (unless in an alternative causative factor \[e.g., Gilbert?s syndrome] is identified) 22\) Known or suspected allergies to enoxaparin or prior heparin\-induced thrombocytopenia 23\) Use of bevacizumab (Avastin) therapy within the previous 6 months or planned use during the study period 24\) Presently receiving oral anticoagulant therapy 25\) Presently receiving oral antiplatelet therapy other than aspirin at a dose ≤ 165 mg. 26\) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study 27\) Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study 28\) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the recommended minimum treatment duration of 6 days 29\) Subjects unwilling or unable to comply with study procedures (e.g., bilateral compression ultrasound) specified in the protocol 30\) Subjects who have previously been randomized in an experimental study of apixaban