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Dipyridamol opbouw in secundaire preventie van beroerte.


- candidate number9809
- NTR NumberNTR2950
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2011
- Secondary IDs2010-022913-25 / NL34184.101.10 METC / CCMO
- Public TitleDipyridamol opbouw in secundaire preventie van beroerte.
- Scientific TitleA prospective randomised open label study to determine the best dose escalation schema of dipyridamole added to acetylsalicylic acid, based on the side-effect headache, in patients starting secondary preventive therapy for stroke.
- ACRONYMDOSE
- hypothesisTreatment starting with a low dose dipyridamole reduces the side-effect headache with 25%.
- Healt Condition(s) or Problem(s) studiedStroke, Stroke, Headache, TIA, Dipyridamole
- Inclusion criteria1. Age > 18 years;
2. Ischemic CVA or TIA;
3. Patients starting treatment with acetylsalicylic acid combined with dipyridamole accoriding to Dutch standards;
4. Able to fill out a diary.
- Exclusion criteriaPatients not starting treatment with acetylsalicylic acid and dipyrdamole according to Dutch standards.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2011
- planned closingdate1-feb-2012
- Target number of participants114
- InterventionsTwo study arms, 4 weeks medication.
Both arms: Two weeks acetylsalicylic acid 160 mg once daily and week 3 and 4 80 mgs once daily. Further:
1. Week 1 and 2, 200 mgs dipyridamole retard once daily. Week 3 and 4 dipyridamole retard 200 mgs twice daily;
2. Week 1, 75 mgs dipyridamole once daily. Week 2, 75 mgs dipyrdidamole twice daily. Week 3, 200 mgs retard once daily and week 4 200 mgs retard twice daily.
- Primary outcomeHeadache frequency.
- Secondary outcomeN/A
- TimepointsPatients fill out a diary on day 1, 3, 5, 7, 14, 21 and 28 of the study period.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES N.C.M. Vos, de
- CONTACT for SCIENTIFIC QUERIES N.C.M. Vos, de
- Sponsor/Initiator Albert Schweitzer Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Albert Schweitzer Ziekenhuis, Dordrecht
- PublicationsN/A
- Brief summaryThe ESPS2 (1996) and ESPRIT (2006) studies have proven that secondary preventive therapy with acetylsalicylic acid combined with dipyridamole is more effectiev preventive therapy after stroke than treatment with one of the components. Headache is a frequent side-effect of dipyridamole. Dose escalation helps to reduce this side-effect. National and international guidelines state that dipyridamole dose has to be escalated gradually, but non of the guidelines mentions a dose escalation scheme. In practice different hospitals use different schemes. There is no research that indicates the best dose escalation scheme.
- Main changes (audit trail)
- RECORD23-jun-2011 - 6-jul-2011


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