A prospective randomised open label study to determine the best dose escalation scheme of dipyridamol added to acetylsalicylic acid, based on the side-effect headache, in patients starting secondary preventive therapy for stroke

The ESPS2 (1996) and ESPRIT (2006) studys have proven that secondary preventive
therapy with acetylsalicylic acid combined with dipyridamole is more effective
than treatment with one of the components.
Headache is a frequent side-effect of treatment with dipyridamole. Eight
percent of participants in the two trials mentioned above quit therapy because
of headaches.
Numerous trials investigated dose escalation schemes to reduce headaches from
dipyridamole. Dose escalation helps to reduce the side-effect headache, but not
less patients quit therapy.
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 to reduce
the side-effect headache from dipyridamole.
We expect that treatment starting with a low dose dipyridamole reduces the
side-effect headache with 25%.

To determine the best dose escalation scheme of dipyridamole added to
acetylsalicylic acid, based on the side-effect headache, in patients starting
secondary preventive therapy for stroke

A prospective randomised open label study

Patients are randomised into two treatment arms. All patients receive two week
acetylsalicyl acid 160 mg once daily and for the following two weeks 80 mg once
daily.
Dipyridamole is added to this treatment:
Arm A: week 1 and 2: dipyridamol 200 mg retard once daily, week 3 and 4: twice
daily
Arm B: week 1 dipyridamole 75 mg once daily, week 2: twice daily, week 3:
dipyridamole 200 mg retard once daily, week 4 twice daily

Patients have to fill out a diary and take medications according to schedule