Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Pfizer |
---|---|
Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00344019 |
This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention [PCI] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.
Condition | Intervention |
---|---|
Coronary Disease |
Drug: atorvastatin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Single-Dose Atorvastatin on Peri-Procedural Myonecrosis During Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes - The NO-MI Study |
Estimated Enrollment: | 150 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Allen Jeremias, MD | 617-632-7782 | ajeremias@gmail.com |
Contact: Joseph Carrozza, Jr, MD | 617-632-7455 | jcarrozz@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Joseph Carrozza, Jr, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 2006-P-000035/1 |
Study First Received: | June 22, 2006 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00344019 |
Health Authority: | United States: Institutional Review Board |
Acute coronary syndrome Percutaneous coronary intervention Peri-procedure myocardial infarction |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Arteriosclerosis Ischemia Infarction Myocardial Infarction Atorvastatin Coronary Artery Disease |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |