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

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ClinicalTrials.gov Identifier: NCT02207725
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : September 27, 2017
Sponsor:
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
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02207725


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov 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
Anticoagulation
Antidote
Apixaban
Anti-fXa inhibitor
PRT4445
Eliquis
Reversal agent

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