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

Portola Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Bleeding

Treatments: Other: Placebo; Biological: Andexanet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02207725

14-503

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Andexanet

Experimental group

Description:

Andexanet (antidote)

Treatment:

Biological: Andexanet

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo