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Reversal of oral anticoagulants rivaroxaban and apixaban, by two different dosages of prothrombin complex concentrate (Cofact®).


- candidate number13198
- NTR NumberNTR3559
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2012
- Secondary IDs 
- Public TitleReversal of oral anticoagulants rivaroxaban and apixaban, by two different dosages of prothrombin complex concentrate (Cofact®).
- Scientific TitleReversal of oral direct factor Xa inhibitors rivaroxaban and apixaban, by two different dosages of prothrombin complex concentrate (Cofact®).
- ACRONYMCOFACTII
- hypothesisReversibility of oral direct factor Xa inhibitors rivaroxaban and apixaban will be the same when a lower dosage of prothrombin complex concentrate (Cofact®) is used. Infusion with doses of 37.5 or 25 units/kg of PCC would be able to reverse the anticoagulant effect of rivaroxaban and apixaban.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria1. Healthy male subjects as documented by laboratory screen tests (including HIV/HBV/HCV screening), personal medical history and normal physical examination;
2. Age ≥18 years, < 50 years;
3. No personal history of thrombotic disease/bleeding disorders;
4. No significant family history of thrombotic disease/bleeding disorders, such as recurrent thrombotic/bleeding events or thrombotic/bleeding events in the absence of any risk factors;
5. Able to provide written informed consent.
- Exclusion criteria1. History of allergic reaction to blood products;
2. Current participation in any other investigational drug study or within the past 30 days;
3. Presence of any condition that, as judged by the investigator, would place the subject at increased risk of harm if he participated in the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2012
- planned closingdate1-jun-2013
- Target number of participants12
- InterventionsIntravenous administration of PCC (Cofact) 25 IU/kg or PCC (Cofact) 37.5 IU/kg or placebo (saline).
- Primary outcomeThe primary outcome is the reversal (normalisation) of coagulation assays, at the end of oral f-Xa inhibitor administration and after the infusion of PCC or placebo.
- Secondary outcomeN/A
- TimepointsDay -7: Randomization for PCC or saline, baseline coagulation tests;
Days -7 to 0:
1. Group 1: Apixaban orally, 10 mg twice daily, for 7 and a half days (15 doses);
2. Group 2: Rivaroxaban orally, 15 mg twice daily, for 7 and a half days (15 doses).
Day 0: PCC/saline administration, scheduled coagulation tests;
Day 1: Scheduled coagulation tests.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. S. Middeldorp
- CONTACT for SCIENTIFIC QUERIESDr. S. Middeldorp
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Blood Supply
- PublicationsReversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate: A Randomized, Placebo-Controlled, Crossover Study in Healthy Subjects.
Elise S. Eerenberg, MD; Pieter W. Kamphuisen, MD; Meertien K. Sijpkens, BSc; Joost C. Meijers, PhD; Harry R. Buller, MD; Marcel Levi, MD
- Brief summaryRivaroxaban and apixaban lack a specific reversal agent. Fifty units/kg of 4-factor prothrombin complex concentrate (PCC, Cofact®) completely reversed the anticoagulant effect of rivaroxaban in healthy subjects. We hypothesized that infusion with doses of 37.5 or 25 units/kg of PCC would be able to reverse the anticoagulant effect of rivaroxaban and apixaban, both factor Xa inhibitors. In a randomized, double blind, placebo-controlled study, 12 healthy volunteers taking rivaroxaban 15 mg or apixaban 10 mg twice daily, received either a single bolus of PCC 37.5 units/kg, PCC 25 units/kg or placebo, with a wash-out period of 18 days in between infusions. The primary outcome was the effect of PCC on measures of thrombin generation, e.g. endogenous thrombin potential (ETP), after PCC or placebo infusion.
- Main changes (audit trail)2-2-14: target number changed into 12 instead of 24.
- RECORD2-aug-2012 - 2-feb-2014


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