No registrations found.
ID
Source
Brief title
Health condition
neurology, dipyridamole, headache, stroke, neurologie, dipyridamol, hoofdpijn, beroerte, CVA, TIA
Sponsors and support
Intervention
Outcome measures
Primary outcome
Headache frequency.
Secondary outcome
N/A
Background summary
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.
Study objective
Treatment starting with a low dose dipyridamole reduces the side-effect headache with 25%.
Study design
Patients fill out a diary on day 1, 3, 5, 7, 14, 21 and 28 of the study period.
Intervention
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.
Postbus 444
N.C.M. Vos, de
Dordrecht 3300 AK
The Netherlands
+31 (0)78 6542538
n.c.m.vos-koppelaar@asz.nl
Postbus 444
N.C.M. Vos, de
Dordrecht 3300 AK
The Netherlands
+31 (0)78 6542538
n.c.m.vos-koppelaar@asz.nl
Inclusion criteria
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.
Exclusion criteria
Patients not starting treatment with acetylsalicylic acid and dipyrdamole according to Dutch standards.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2809 |
| NTR-old | NTR2950 |
| Other | METC / CCMO : 2010-022913-25 / NL34184.101.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |