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

Portola Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Bleeding

Treatments: Other: Placebo; Biological: Andexanet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220725

14-504

Details and patient eligibility

About

The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.

Enrollment: 80 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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80 participants in 2 patient groups

Andexanet 800mg bolus (Part I)

Experimental group

Description:

Andexanet (antidote) - 800 mg bolus

Treatment:

Other: Placebo

Biological: Andexanet

Andexanet 800mg + 960mg (Part II)

Experimental group

Description:

800 mg bolus + 960 mg infusion (8 mg/min)

Treatment:

Other: Placebo

Biological: Andexanet