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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00767663 |
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.
Condition | Intervention | Phase |
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Coronary Heart Disease Percutaneous Transluminal Coronary Angioplasty Atherosclerosis |
Drug: dipyridamole Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI |
Estimated Enrollment: | 200 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
dipyridamole
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Drug: dipyridamole
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
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2: Placebo Comparator
placebo
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Drug: placebo
placebo twice daily, minimal three days pretreatment
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stijn Wouters, MD | +31 24 3616723 | c.wouters@cardio.umcn.nl |
Contact: Anja Rasing, BSc | +31 24 3611111 ext 1275 | A.Rasing-Hoogveld@ncmls.ru.nl |
Netherlands | |
RUNMC | Recruiting |
Nijmegen, Netherlands, 6500HB | |
Contact: Stijn Wouters, MD +31 24 3616723 c.wouters@cardio.umcn.nl | |
Principal Investigator: Gerard Rongen, MD PhD |
Principal Investigator: | Gerard Rongen, MD PhD | RUNMC |
Responsible Party: | RUNMC ( G. Rongen MD PhD ) |
Study ID Numbers: | P3 |
Study First Received: | October 6, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00767663 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: Medicines Evaluation Board (MEB) |
Atherosclerosis Arterial Occlusive Diseases Vasodilator Agents Heart Diseases Myocardial Ischemia Vascular Diseases Cardiovascular Agents |
Arteriosclerosis Ischemia Coronary Disease Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors Dipyridamole Coronary Artery Disease |
Atherosclerosis Arterial Occlusive Diseases Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Hematologic Agents Vascular Diseases Enzyme Inhibitors Cardiovascular Agents |
Arteriosclerosis Pharmacologic Actions Coronary Disease Phosphodiesterase Inhibitors Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Dipyridamole Coronary Artery Disease |