MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED EFFICACY AND SAFETY STUDY COMPARING EXTENDED DURATION BETRIXABAN WITH STANDARD OF CARE ENOXAPARIN FOR THE PREVENTION OF VENOUS THROMBOEMBOLISM IN ACUTE MEDICALLY ILL PATIENTS

Portola Pharmaceuticals, Inc.,0 个研究点目标入组 152 人开始时间: 2012年11月20日最近更新: 2023年9月4日

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•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.

•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

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