Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
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|ClinicalTrials.gov Identifier: NCT02585713|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2015
Last Update Posted : June 7, 2019
This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Vein Thrombosis Deep Vein Thrombosis Gonadal Thrombosis Hepatic Thrombosis Malignant Neoplasm Mesenteric Thrombosis Metastatic Malignant Neoplasm Portal Vein Thrombosis Pulmonary Embolism Renal Vein Thrombosis Splenic Thrombosis Venous Thromboembolism||Drug: Apixaban Drug: Dalteparin Other: Questionnaire Administration||Phase 3|
I. Any episode of major bleeding including fatal bleeding.
I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism.
II. Any episode of major bleeding including fatal bleeding or any episode of clinically relevant non-major bleeding.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC) once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
After completion of study treatment, patients are followed up at 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||315 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism|
|Actual Study Start Date :||November 20, 2015|
|Actual Primary Completion Date :||April 2, 2018|
|Estimated Study Completion Date :||November 20, 2019|
Experimental: Arm I (apixaban)
Patients receive apixaban 10 mg PO BID on days 1-7 and lower-dose apixaban 5 mg PO BID on days 8-180.
Other: Questionnaire Administration
Experimental: Arm II (dalteparin)
Patients receive dalteparin 200 IU/kg/day SC QD on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
Other: Questionnaire Administration
- Episode of major bleeding including fatal bleeding [ Time Frame: Up to 7 days after treatment termination ]Patients will be analyzed according to the drug they received. Major bleeding events observed after 7 days will be described separately. The frequency of major bleeding events will be summarized separately by treatment arm. The cumulative incidence of major bleeding at 6 months from treatment initiation and its associated 95% confidence interval will be estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk. A Cox proportional hazard model will be used to determine the point estimate for the hazard ratio (comparing apixa
- Incidence of bleeding event defined as a major bleed or a clinically relevant non-major bleed [ Time Frame: Up to 7 days after treatment termination ]A similar analysis as described for the primary safety analysis will be used. The impact of baseline covariates on the safety outcome will be explored by adjusting for them in the Cox models. The frequencies of the separate components contributing to the safety outcome will be described. Incidence of adverse events will be coded using the MedDRA Dictionary.
- Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) [ Time Frame: Up to 3 months post-treatment ]Analyzed using the same methods described above for the primary endpoint. The impact of baseline covariates (location of DVT, renal clearance, age, sex, mobility at randomization, pulmonary disease, and cardiac disease) on the efficacy outcome will be explored adjusting for them in the Cox models. There is no adjustment for multiple comparisons. This analysis will be conducted at the one-sided type I error of 0.05. The assumption of proportional hazards will be checked for all Cox models (including primary and secondary endpoints) using graphical methods as log(-log)-plots and plots of scaled
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585713
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Illinois|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Peoria, Illinois, United States, 61615|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Siouxland Regional Cancer Center|
|Sioux City, Iowa, United States, 51101|
|United States, Kansas|
|Cancer Center of Kansas - Wichita|
|Wichita, Kansas, United States, 67214|
|United States, Michigan|
|Cancer Research Consortium of West Michigan NCORP|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Coborn Cancer Center at Saint Cloud Hospital|
|Saint Cloud, Minnesota, United States, 56303|
|Metro Minnesota Community Oncology Research Consortium|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New Hampshire|
|New Hampshire Oncology Hematology PA-Hooksett|
|Hooksett, New Hampshire, United States, 03106|
|United States, North Carolina|
|FirstHealth of the Carolinas-Moore Regional Hosiptal|
|Pinehurst, North Carolina, United States, 28374|
|United States, Ohio|
|Columbus NCI Community Oncology Research Program|
|Columbus, Ohio, United States, 43215|
|Toledo Clinic Cancer Centers-Toledo|
|Toledo, Ohio, United States, 43623|
|United States, Pennsylvania|
|Guthrie Medical Group PC-Robert Packer Hospital|
|Sayre, Pennsylvania, United States, 18840|
|United States, South Dakota|
|Rapid City Regional Hospital|
|Rapid City, South Dakota, United States, 57701|
|Principal Investigator:||Robert McBane||Academic and Community Cancer Research United|