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Sponsored by: |
University Hospital, Motol |
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Information provided by: | University Hospital, Motol |
ClinicalTrials.gov Identifier: | NCT00469326 |
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: Atorvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study |
Enrollment: | 200 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
atorvastatin: Active Comparator
atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
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Drug: Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI
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control: No Intervention
PCI without atorvastatin pretreatment
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Drug: Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI
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Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
Department of Cardiology, CardioVascular Center, University Hospital Motol | |
Prague, Czech Republic, 150 18 |
Study Chair: | Josef Veselka, Prof., PhD. | Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic |
Responsible Party: | University Hospital Motol ( University Hospital Motol ) |
Study ID Numbers: | KC EK-361/05 |
Study First Received: | May 3, 2007 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00469326 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control |
coronary artery disease percutaneous coronary intervention atorvastatin |
Arterial Occlusive Diseases Antimetabolites Heart Diseases Myocardial Ischemia Antilipemic Agents Vascular Diseases Ischemia |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease Coronary Artery Disease Atorvastatin |
Arterial Occlusive Diseases Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors Arteriosclerosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease Atorvastatin |