Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:April 13, 2017
End Date:June 2019
Contact:Giancarlo Agnelli, MD
Email:giancarlo.agnelli@unipg.it
Phone:+390755786424

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Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective
randomized open blinded end-point (PROBE) study


Inclusion Criteria:

- Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or
unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a
segmental or more proximal pulmonary artery;

- Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin,
primary brain tumor or intracerebral metastasis and acute leukemia);

- Signed and dated informed consent of the patient, available before the start of any
specific trial procedure.

Exclusion Criteria:

- age <18 years;

- ECOG Performance Status III or IV;

- life expectancy of less than 6 months;

Related to anticoagulant treatment:

- administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin
(UFH) for more than 72 hours before randomization;

- 3 or more doses of a vitamin K antagonist before randomization;

- thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index
episode;

- indication for anticoagulant treatment for a disease other than the index VTE episode;

Related to bleeding risk:

- thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg
daily or dual antiplatelet therapy;

- active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;

- recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic
surgery

- hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or
history of heparin induced thrombocytopenia;

- creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;

- acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher
the upper limit of the normal range;

- uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite
antihypertensive treatment);

- concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and
P-Glycoprotein;

Standard criteria:

- bacterial endocarditis;

- hypersensitivity to the active substance or to any of the excipients of study drug;

- patients participation in other pharmaco therapeutic program with an experimental
therapy that is known to effect the coagulation system;

- childbearing potential without proper contraceptive measures, pregnancy, or breast
feeding;

- any condition that as judged by the Investigator would place the subject at increased
risk of harm if he/she participated in the study.
We found this trial at
18
sites
Jacksonville, Florida 32216
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Boston, Massachusetts 02115
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Brussels,
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Jacksonville, Florida 32207
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Jacksonville, FL
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Rochester, Minnesota 55905
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Rochester, MN
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Staten Island, NY
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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