MDACC Study Summary 2007-0907 (Archived)

Study Summary
No. 2007-0907:.......Other Supportive......Saroj Vadhan-Raj......Cytokines and Supportive Care

Study Summary Title



Study Summary Number:	2007-0907

Study Title:	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 Ill Medical Subjects During and Following Hospitalization

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Cytokines and Supportive Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Other Supportive	Supported By:	Bristol Myers Squibbs

Phase of Study:	Phase III	Return Visit:	3 times - Day 30 +/- 2 days (Visit 4); Day 60 +/- 7 days (Visit 5); Day 90 +/-7 days(Visit 6)

Treatment Agents:	Apixaban Enoxaparin	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	6 days after randomization


Description/ Intervention:	The goal of this clinical research study is to compare apixaban and Lovenox (enoxaparin) to learn which one may better help to reduce VTE. The safety of these drugs will also be studied.

Study Objectives / Outcomes

Primary Objectives:
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a minimum period of 6 days, in subjects with acute medical illness. Total VTE is defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT detected by bilateral compression ultrasound. VTE-related death is defined as sudden death for which VTE can not be excluded as a cause.

Secondary Objectives:

To demonstrate that oral administration of apixaban 2.5 mg BID is not inferior to
subcutaneous administration of enoxaparin 40 mg QD for the prevention of total VTE
and VTE-related death occurring up to the time of discontinuation of parenteral
therapy.
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces
the rate of total VTE and all cause death compared to subcutaneous administration of
enoxaparin 40 mg QD.
To assess the effect of orally-administered apixaban 2.5 mg BID on the incidence and
time to occurrence of symptomatic PE and symptomatic DVT.
To assess the effect of orally-administered apixaban 2.5 mg BID on the rate of
all-cause mortality at 30 and 90 days after randomization.

The secondary safety objectives are:

To assess the effect of orally administered apixaban 2.5 mg BID for 30 days on the
rate of major bleeding.
To assess the effect of orally administered apixaban 2.5 mg BID for 30 days on the
rate of clinically relevant non-major bleeding and on the composite of major bleeding
and clinically relevant non-major bleeding.
To demonstrate that orally administered apixaban 2.5 mg BID for 30 days is generally
safe and well tolerated in this patient population.

Study Status Information



Study Activation / Registration Date:	10/22/2008

IRB Review and Approval Date:	03/28/2008

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	6524

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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; 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)

6) Men and women, of any race, at least 40 years of age

7) 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.

8) 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.

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 ongoing treatment with parenteral or two or more oral antiplatelet agents

8) Active liver disease

9) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings.

10) Severe renal disease as evidenced by creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault .

11) Subjects hospitalized more than 72 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 in the past 14 days have received treatment over consecutive days with: more than three doses of enoxaparin or another low molecular weight heparin; more than three doses of fondaparinux; more than six doses of unfractionated heparin; an infusion of unfractionated heparin for more than 72 hours; 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 < 9 g/dL, Platelet count < 100,000/mm^3 Abnormal liver function tests: ALT or AST >3 X ULN or ALT or AST > 2 X ULN without identification of an alternative causative factor or bilirubin (direct or total) > 1.5 X ULN (unless in an alternative causative factor [e.g., Gilbert's syndrome] is identified)

21) Known or suspected allergies to enoxaparin or prior heparin-induced thrombocytopenia

22) Use of bevacizumab (Avastin�) therapy within the previous 6 months or planned use during the study period

23) Presently receiving oral anticoagulant therapy

24) Presently receiving dual oral antiplatelet therapy or aspirin at a dose >/=165 mg.

25) 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

26) Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study

27) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the minimum treatment duration of 6 days

28) Subjects unwilling or unable to comply with study procedures (e.g., bilateral compression ultrasound) specified in the protocol

29) Subjects who have previously been randomized in an experimental study of apixaban

Links

Registration Number: NCT00457002
Study Information on Clinical Trials Registry (clinicaltrials.gov)