Treatment starting with a low dose dipyridamole reduces the side-effect headache with 25%.
ID
Bron
Verkorte titel
Aandoening
neurology, dipyridamole, headache, stroke, neurologie, dipyridamol, hoofdpijn, beroerte, CVA, TIA
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Headache frequency.
Achtergrond van het onderzoek
The 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.
Doel van het onderzoek
Treatment starting with a low dose dipyridamole reduces the side-effect headache with 25%.
Onderzoeksopzet
Patients fill out a diary on day 1, 3, 5, 7, 14, 21 and 28 of the study period.
Onderzoeksproduct en/of interventie
Two 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.
Publiek
Postbus 444
N.C.M. Vos, de
Dordrecht 3300 AK
The Netherlands
+31 (0)78 6542538
n.c.m.vos-koppelaar@asz.nl
Wetenschappelijk
Postbus 444
N.C.M. Vos, de
Dordrecht 3300 AK
The Netherlands
+31 (0)78 6542538
n.c.m.vos-koppelaar@asz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients not starting treatment with acetylsalicylic acid and dipyrdamole according to Dutch standards.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2809 |
NTR-old | NTR2950 |
Ander register | METC / CCMO : 2010-022913-25 / NL34184.101.10 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |