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Prothrombin complex concentrate (Cofact ) as a potential antidote for novel anticoagulants Dabigatran and Rivaroxaban.


- candidate number7905
- NTR NumberNTR2272
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2010
- Secondary IDsMEC 09/206 AMC 2009-219
- Public TitleProthrombin complex concentrate (Cofact ) as a potential antidote for novel anticoagulants Dabigatran and Rivaroxaban.
- Scientific TitleAbility of prothrombin complex concentrate (Cofact ) to reverse the anticoagulant effect of novel antithrombotic agents.
- ACRONYM
- hypothesisBased on its general pro-hemostatic potential, prothrombin complex concentrate may be effective in (completely or partially) reversing the anticoagulant effect of the new antithrombotic agents Dabigatran and Rivaroxaban.
- Healt Condition(s) or Problem(s) studiedAnticoagulants
- Inclusion criteria1. Healthy males between 18-50 year;
2. No medical history of thrombotic disease or bleeding disorders;
3. Normal physical examination and laboratory screen;
4. Negative HIV-1, hepatitis B and hepatitis C serology.
- Exclusion criteria1. History of allergic reaction to blood products;
2. Current participation in any other investigational drug study or within the past 30 days.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2010
- planned closingdate1-dec-2010
- Target number of participants12
- InterventionsSubjects will be divided into two groups. Subjects in group 1 will take Dabigatran 2dd 150 mg on day -2, -1 and 0. Subjects in group 2 will take Rivaroxaban 2dd 20 mg on day -2, -1 and 0. After the fifth dose (on day 0) subjects will be randomized to receive Cofact (50 U/kg) or a similar volume of Saline as a single bolus dose i.v. over 15 minutes. After a 10 day wash-out period the procedure is repeated but the alternative treatment (Saline of Co-fact) is administered.
- Primary outcomeThe primary outcome is activation and inhibition of coagulation, as reflected by coagulation tests.
- Secondary outcomeN/A
- TimepointsSubjects will start their oral medication at day -2. They will be admitted to the study ward on day 0. An i.v. catheter will be placed to withdraw blood samples. Blood samples are collected at the following times:
T= day -2 (before starting the oral anticoagulants), T= 0 (before the administration of Cofact/ Saline), and after the administration of Cofact/Saline at T= 15 min, 30 min, 60 min, 120 min, 240 min, 360 min and at 24 hrs.
The following assays will be performed: aPTT, PT, thrombin time (TT), Ecarin-clotting time (ECT), endogenous thrombin potential (ETP), prothrombin activation fragment F1+2, thrombin-antithrombin complex, thrombelastography, anti-factor Xa (in case of rivaroxaban), anti-factor IIa (in case of dabigatran).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD Elise Eerenberg
- CONTACT for SCIENTIFIC QUERIESProf. dr. M.M. Levi
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Blood Supply
- PublicationsN/A
- Brief summaryAn investigator initiated double blind cross-over study of the activation and inhibition of coagulation in healthy males who receive either Cofact or placebo after the administration of a novel anticoagulant. The two novel anticoagulants given are Dabigatran and Rivaroxaban. Blood samples will be collected at set times to assess coagulation assays.
- Main changes (audit trail)
- RECORD6-apr-2010 - 22-apr-2010


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