Atherosclerosis Clinical Trial
Official title:
Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI
In this study the investigators will investigate whether a short pretreatment (3-7 days)
with dipyridamole 200mg twice daily will protect patients against myocardial injury
sustained during an elective dotter operation of the coronary arteries (PCI).
The investigators hypothesize that dipyridamole can reduce myocardial injury sustained
during elective PCI.
Rationale:
In elective PCI (percutaneous coronary intervention) up to 40% of the patients show an
asymptomatic rise in myonecrosis marker troponin-I. This release of troponin-I has been
found to represent irreversible myocardial injury and has been related to an increased risk
of restenosis and even long-term mortality. Dipyridamole has been proven to induce
protection against ischemia reperfusion injury and to reduce risk of cardiovascular death or
event in secondary prevention after TIA or CVA.
Objective:
To test the hypothesis that dipyridamole improves tolerance to ischemia reperfusion injury
in patients undergoing elective PCI.
Study design:
Double-blind placebo controlled intervention study
Study population:
Patients undergoing elective PCI
Intervention:
pretreatment with dipyridamole (Persantin Retard) 2dd 200mg or placebo.
Main study parameters:
Periprocedural troponin-I release measured 8 hours after PCI.
Bioequivalence study:
before the start of th clinical trial we will perform a bioequivalent study to test whether
our study medication (blinded by recapsuling) equals original dipyridamole capsules. 6
Healthy volunteers in a cross-over randomised design will take original dipyridamole 200 mg
SR and recapsuled dipyridamole 200mg SR (prepared by the department of pharmacy of the
RUNMC). Plasma dipyridamole concentration will be measured frequently and at baseline and 1
and 3 hours after administration of dipyridamole nucleoside transport inhibitions of
erythrocytes will be measured, to assess drug activity.
The clinical trial will only be initialized after conformation of bioequivalence of the
study medication to the original dipyridamole.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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