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Sponsored by: |
University of Roma La Sapienza |
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Information provided by: | University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT00751491 |
Percutaneous coronary intervention(PCI)is associated with up to 30%incidence of myonecrosis,as reflected by elevation of cardiac enzymes in a successful procedure. Apart from side-branch occlusion,intimal dissection and coronary spasm,a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption causing obstruction of blood flow at capillary level resulting in micro-infarction.Recent studies have suggested that pretreatment with adenosine in the cath lab and Clopidogrel and statins > 6 hours before may be associated with a reduction in infarct size after reperfusion therapy for acute myocardial infarction.Whether pretreatment with adenosine decreases the incidence of myonecrosis in patients undergoing non urgent PCI is not fully known. We propose that adenosine-induced hyperaemia can potentially ameliorate the deleterious effects of distal embolization associated with non-urgent PCI through dilatation of the microvasculature.Mechanistically,this may reduce capillary obstruction by facilitating the throughput passage of embolized platelet thrombi out to the venous end of the coronary circulation,thereby reducing the incidence of post-PCI myonecrosis.In this prospective,randomized,open-label study,we evaluated the incidence of myonecrosis after non-urgent PCI with a treatment with intracoronary adenosine compared with pretreatment of loading dose of Clopidogrel 300/600 mg >/< 6 hours.
Condition | Intervention | Phase |
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Stable Angina Percutaneous Coronary Intervention |
Drug: Adenosin,Clopidogrel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Evaluation of Adenosin Intracoronary Infusion Versus Clopidogrel Pretreatment on Myonecrosis Occurence in Elective PCI |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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III: Active Comparator |
Drug: Adenosin,Clopidogrel
Intracoronary Adenosin 50microg Clopidogrel 300/600mg
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A: Active Comparator |
Drug: Adenosin,Clopidogrel
Intracoronary Adenosin 50microg Clopidogrel 300/600mg
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME ( GENNARO SARDELLA ) |
Study ID Numbers: | SARD55 |
Study First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751491 |
Health Authority: | Italy: Ethics Committee |
Stable angina Percutaneous Coronary Intervention Myonecrosis |
Clopidogrel Angina Pectoris |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Pharmacologic Actions |