CompletedPhase 3

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

United States80 participantsStarted 2014-05

Plain-language summary

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

Who can participate

Age range50 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II)

Timeframe: Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)

Trial details

NCT IDNCT02220725

SponsorPortola Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Results submitted2018-05-18

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