NCT00767663

Persantin Preceding Elective PCI

Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Heart Disease
• Percutaneous Transluminal Coronary Angioplasty
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	dipyridamole	dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
DRUG	placebo	placebo twice daily, minimal three days pretreatment

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2008-10-07
• Last updated: 2015-10-30

Locations

2 sites across 1 country: Netherlands