Apixaban for Secondary Prevention of Thromboembolism Among Patients With AntiphosPholipid Syndrome (ASTRO-APS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02295475|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome Thrombosis||Drug: Apixaban Drug: Warfarin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apixaban for the Secondary Prevention of Thromboembolism: a Prospective Randomized Outcome Pilot Study Among Patients With the AntiphosPholipid Syndrome|
|Actual Study Start Date :||December 10, 2014|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
Subjects will receive apixaban 5 mg tablets taken twice daily for the duration of the study.
Other Name: Eliquis
Active Comparator: Warfarin
Subjects will receive warfarin for the duration of the study, with the dose and frequency adjusted per clinician discretion to achieve an INR (International Normalized Ratio) between 2 and 4.
Other Name: Coumadin
- Rate (number divided by duration) of clinically overt thromboses (arterial and/or venous) or vascular death [ Time Frame: From time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment ]
- Rate (number divided by duration) of occurrence of major (including fatal) and clinically relevant non-major bleeding [ Time Frame: From time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment ]Major bleeding is clinically overt bleeding accompanied by one or more of the following: a decrease in the hemoglobin level of 2 g per deciliter or more, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding. Clinically relevant non-major bleeding is defined as clinically overt bleeding that does not satisfy the criteria for major bleeding and that led to hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy.
- Net clinical benefit (combination of occurrence of thrombosis and bleeding rates) [ Time Frame: From time of first dose of study drug through 2 days after receiving the last dose of study drug at the end of 12 months of treatment ]Sum of number of thrombosis and bleeding events divided by duration
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): NCT02295475
|United States, Ohio|
|The James Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, Utah|
|Intermountain Medical Center|
|Murray, Utah, United States, 84107|
|Principal Investigator:||Scott C Woller, MD||Intermountain Health Care, Inc.|