None listed
Conditions
Interventions
PATIENTS WILL BE RANDOMIZED 1:1 TO ONE OF TWO TREATMENT GROUPS. RANDOMIZATION KITS WILL INCLUDE EITHER BETRIXABAN AND ENOXAPARIN PLACEBO OR ENOXAPARIN AND BETRIXABAN PLACEBO. THE PATIENTS WILL CONTINU
Sponsors
Portola Pharmaceuticals, Inc.,
Eligibility
Age
40 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MALE OR FEMALE, AGE ≥ 40 YEARS. (PATIENTS AGED 40 TO ≤ 60 YEARS MAY BE INCLUDED ONLY IF THEY HAVE AS ONE OF THEIR ADDITIONAL RISK FACTORS FOR VTE, EITHER PREVIOUS HISTORY OF VTE OR HISTORY OF CANCER AS LISTED UNDER CRITERION # 6 BELOW AND MEET THE REST OF THE ELIGIBILITY CRITERIA. 2. WOMEN OF CHILDBEARING POTENTIAL MUST HAVE A NEGATIVE SERUM PREGNANCY TEST PRIOR TO RANDOMIZATION AND MUST BE WILLING TO USE AN ACCEPTABLE METHOD OF CONTRACEPTION TO AVOID PREGNANCY THROUGHOUT THE STUDY. ACCEPTABLE METHODS OF CONTRACEPTION INCLUDE TUBAL LIGATION, ORAL CONTRACEPTIVE, BARRIER METHODS (INTRA-UTERINE DEVICE, DIAPHRAGM, FEMALE CONDOM, MALE CONDOM). ABSTINENCE IS AN ACCEPTABLE FORM OF CONTRACEPTION, ONLY INSOFAR AS PATIENTS AGREE TO USE ANOTHER ACCEPTABLE METHOD OF BIRTH CONTROL, PREFERABLY A BARRIER METHOD, IF THEY BECOME SEXUALLY ACTIVE. 3. WILLING TO SIGN INFORMED CONSENT AND FOLLOW STUDY PROCEDURES. 4. PATIENTS MUST BE ANTICIPATED TO BE SEVERELY IMMOBILIZED FOR AT LEAST 24 HOURS AFTER RANDOMIZATION AND ANTICIPATED TO BE SEVERELY OR MODERATELY IMMOBILIZED FOR ≥ 4 DAYS AFTER RANDOMIZATION IN ANY TYPE OF CARE SETTING (E.G. HOSPITAL, INTERMEDIATE CARE OR REHABILITATION CENTER, MANAGED CARE IN HOME ETC.) AND WITH ADDITIONAL ANTICIPATED MODERATE MOBILITY THEREAFTER.
Exclusion criteria
Exclusion criteria: 1. HOSPITALIZED > 96 HOURS BEFORE RANDOMIZATION. (TIMING OF HOSPITALIZATION BEGINS WHEN ADMITTING ORDERS ARE WRITTEN). 2. UNABLE TO TAKE FOOD BY MOUTH (OR BY NASOGASTRIC/FEEDING TUBE, IF ONE IS IN PLACE) 3. CONDITION REQUIRING PROLONGED ANTICOAGULATION (E.G., CONCURRENT EPISODE OF VTE, ATRIAL FIBRILLATION, CARDIAC VALVE PROSTHESIS, ETC.) 4. LIFE EXPECTANCY < 8 WEEKS 5. IN THE OPINION OF THE INVESTIGATOR IT WILL NOT BE POSSIBLE TO OBTAIN AN ADEQUATE BILATERAL COMPRESSION ULTRASOUND EVALUATION (E.G., PATIENTS WITH ABOVE THE KNEE AMPUTATIONS) 6. SUBJECTS UNWILLING OR UNABLE TO COMPLY WITH STUDY PROCEDURES (INCLUDING TWO ULTRASOUND PROCEDURES) OR MEDICATION INSTRUCTIONS INCLUDING THE USE OF ENOXAPARIN OR MATCHING PLACEBO FOR THE MINIMUM DURATION OF 6 DAYS AT RISK OF INCREASED BLEEDING DUE TO: 7. HISTORY OF CLINICALLY SIGNIFICANT BLEEDING (I.E., REQUIRING MEDICAL ATTENTION) WITHIN PREVIOUS 6 MONTHS 8. HISTORY OF ANY SIGNIFICANT GASTROINTESTINAL, PULMONARY OR UROGENITAL BLEEDING, CHRONIC PEPTIC ULCER DISEASE OR GASTRITIS 9. ADMITTING OR CONCOMITANT DIAGNOSIS LIKELY TO REQUIRE MAJOR SURGERY OR OTHER INVASIVE PROCEDURE WITHIN 3 MONTHS
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed