Persantin Preceding Elective PCI (P3)
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.
Coronary Heart Disease
Percutaneous Transluminal Coronary Angioplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI|
- Cardiac troponin-I [ Time Frame: before and 8 hours after PCI ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
Other Name: persantin
Placebo Comparator: 2
placebo twice daily, minimal three days pretreatment
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.
To test the hypothesis that dipyridamole improves tolerance to ischemia reperfusion injury in patients undergoing elective PCI.
Double-blind placebo controlled intervention study
Patients undergoing elective PCI
pretreatment with dipyridamole (Persantin Retard) 2dd 200mg or placebo.
Main study parameters:
Periprocedural troponin-I release measured 8 hours after PCI.
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.
|Nijmegen, Netherlands, 6500HB|
|Canisius Wilhelmina Hospital|
|Nijmegen, Netherlands, 6532SZ|
|Principal Investigator:||Gerard Rongen, MD PhD||RUNMC|