A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban

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. Identifier: NCT02207725
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : September 27, 2017
Information provided by (Responsible Party):
Portola Pharmaceuticals

Brief Summary:
The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.

Condition or disease Intervention/treatment Phase
Bleeding Biological: Andexanet Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Apixaban Anticoagulation With Intravenously Administered Andexanet Alfa
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Andexanet
Andexanet (antidote)
Biological: Andexanet
Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. Reversal of Apixaban anticoagulation effect as measured by anti-factor Xa activity [ Time Frame: 43 Days ]
    To compare reversal of apixaban anticoagulation between Andexanet and placebo as measured by anti-fXa activity, both after a bolus and after a bolus followed by a continuous infusion

Secondary Outcome Measures :
  1. Unbound apixaban plasma levels [ Time Frame: 43 days ]
  2. Thrombin Generation [ Time Frame: 43 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Reasonably healthy men and women aged 50 to 75

Exclusion Criteria:

  • History of abnormal bleeding, active bleeding or risk factors for bleeding
  • History of thrombosis or risk factors for thrombosis
  • History of adult asthma or use of inhaled medications

Information from the National Library of Medicine

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 identifier (NCT number): NCT02207725

United States, Arizona
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Portola Pharmaceuticals
Study Director: Vandana Mathur, M.D. Portola Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals Identifier: NCT02207725     History of Changes
Other Study ID Numbers: 14-503
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2015

Keywords provided by Portola Pharmaceuticals:
Andexanet alpha
Anti-fXa inhibitor
Reversal agent

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action