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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
placebo twice daily, minimal three days pretreatment
RUNMC
Nijmegen, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Cardiac troponin-I
Time frame: before and 8 hours after PCI
Effect of pretreatment with dipyridamole 2x200mg on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)
Time frame: 3 days treatment minimal
Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)
Time frame: before and 8 hours after PCI
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