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More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study


- candidate number25325
- NTR NumberNTR6093
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2016
- Secondary IDs2016 006 20 UMCG Research Registry
- Public TitleMore precise dosing of acenocoumarol in patients aged 80 and above, a pilot study
- Scientific TitleMore precise dosing of acenocoumarol in patients aged 80 and above, a pilot study
- ACRONYMEighty and a half
- hypothesisWe hypothesise that dosing using tablets of half a milligram acenocoumarol increases anticoagulation control
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Pulmonary embolism, Heart valve replacement, Thrombosis
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:

- Using acenocoumarol for any indication, and being managed by Certe Trombosedienst
- 80 years of age or older at time of inclusion
- Using acenocoumarol with an average daily dose of less than 2 milligrams in the previous three months
- Subject provided informed consent
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:

- Initiated therapy with acenocoumarol in the last nine months
- Expected termination of VKA within six months
- Dosing step lower than or equal to "step 7", i.e. usage of less than 3.5 milligrams acenocoumarol per week. Patients who use such a low dose generally have an unfavourable prognosis.
- Patients who determine the acenocoumarol dose themselves
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-okt-2017
- planned closingdate30-okt-2018
- Target number of participants80
- InterventionsOne group is dosed using tablets of 0.5 milligrams of acenocoumarol, while the other group uses the regular 1.0 milligram tablets. Both will be dose-adjusted to their previously determined INR target range.
- Primary outcomeThe main study parameter is quality of anticoagulation (individual time in therapeutic range and INR variability).
- Secondary outcomeThe secondary study parameters are treatment satisfaction, medication errors and number of INR measurements.
- TimepointsStart of study, six months later
- Trial web sitehttp://www.hematologiegroningen.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jasper (J.H.A.) van Miert
- CONTACT for SCIENTIFIC QUERIES Jasper (J.H.A.) van Miert
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Certe Thrombosis Service Groningen, Stichting ter Bevordering van Onderzoek/Onderwijs op het gebied van Hemostase, Trombose en Reologie
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-sep-2016 - 4-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl