| Exclusion Criteria: | 1) Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period. Examples of acceptable birth control methods include: birth control pills, an intrauterine device (IUD), or a double-barrier method (diaphragm with spermicide or condom with spermicide).
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 study drug administration.
5) Prior history of documented DVT or PE.
6) Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer).
7) Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry.
8) Familial bleeding diathesis.
9) Overt metastatic cancer to the brain.
10) Expected survival less than 6 months or ECOG performance equal to or more than 3.
11) Patients who are candidates for bone marrow transplantation within the 12 week treatment period or 30 day follow-up period.
12) Uncontrolled hypertension: (SBP > 200 mmHg and/or DBP > 110 mmHg). Note: All patients with "consistently (greater than 2 separate readings at different sittings, as per JNC VII guidelines) increased blood pressure" (>/= 140/90 mm Hg) will be referred for further assessment and treatment of HTN at the time of trial entry. Patients with a systolic BP >/= 160 mm Hg or diastolic BP >/= 100 mm Hg (Hypertension, Stage 2 per JNC-VII guidelines 5) will not be entered into the trial on that day but referred for further HTN management and, once below these ranges, can be entered into the trial.
13) Presence of coagulopathy (e.g. INR > 1.5 or platelet count < 100x10^9/L if not yet on chemotherapy or < 50 x 10^9/L if receiving chemotherapy); platelet count must be > 100 x 10^9/L prior to starting study medication.
14) One or more of the following: ALT > 3 x ULN, total bilirubin > 2 x ULN, calculated creatinine clearance (Cl subscript cr) < 30 mL/min.
15) Unable to take oral medications.
16) Presently receiving anticoagulant therapy (e.g. mechanical heart valves, atrial fibrillation, etc. Note: patients receiving low dose warfarin, e.g. 1 mg, for CVC may be enrolled provided warfarin is discontinued 3 days prior to study entry.)
17) Use of aspirin (ASA) more than 165 mg/day. Washout period: 7days.
18) Use of Clopidogrel (Plavix). Washout period: 7days.
19) Receiving bevacizumab (Avastin) for off-label/investigational indications.
20) Use of Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin). Washout period: 6 months. Note: Topical azole antifungal agents are permitted.
21) Use of Aggrenox (aspirin-dipyridamole). Washout period: 7 days
22) Use of Pletal (cilostazol). Washout period: 7 days.
23) Use of Nexavar (sorafenib). Washout period: 3months.
24) Use of Sutent (sunitinib). Washout period: 3 months.
25) Use of vitamin E and gingko.
26) Participation in another pharmacotherapeutic study of an investigational agent within 30 days.
27) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
28) Geographically inaccessible for follow-up.
29) Failure to provide written informed consent. |