Effects of Atorvastatin on Myonecrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00344019
First received: June 22, 2006
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Peri-procedural myonecrosis, as measured by troponin T (TnT), during percutaneous coronary intervention (PCI)

Secondary Outcome Measures:
  • Other biomarkers of myocyte injury (CK, CK-MB)
  • Inflammatory markers (CRP)
  • Post PCI growth of tissue level perfusion circumference and tissue level perfusion brightness using digital subtraction angiography

Estimated Enrollment: 150
Study Start Date: July 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be aged 18 or over.
  • Patients must provide written informed consent.
  • Patients are presenting with unstable angina (defined as new onset chest pain, accelerating chest pain, chest pain at rest and ST-segment depression on the electrocardiogram [EKG])
  • Patients undergoing successful coronary stent implantation of the (presumed) culprit lesion (defined as < 50% residual stenosis).

Exclusion Criteria:

  • Any patient who is unable to give written informed consent.
  • Any condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient.
  • Patients presenting with an ST-elevation myocardial infarction (MI).
  • Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).
  • Patients already on high-dose statin therapy (defined as any statin equivalent to atorvastatin ≥ 40 mg).
  • Patients who took any statin agent within 24 hours of presentation to the cardiac catheterization laboratory.
  • Patients with active hepatic disease or myositis, in whom statin therapy is contraindicated.
  • Patients with hypersensitivity to atorvastatin.
  • Patients with procedural complications, including unsuccessful percutaneous transluminal coronary angioplasty (PTCA)/stenting, major side-branch occlusion, flow-limiting dissections at the completion of the procedure, emergent coronary artery bypass surgery, peri-procedural thrombus formation with distal embolization, stent thrombosis within the first 24 hours, repeat emergent PCI within 24 hours, and death within 24 hours.
  • Cardiogenic shock.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344019

Contacts
Contact: Allen Jeremias, MD 617-632-7782 ajeremias@gmail.com
Contact: Joseph Carrozza, Jr, MD 617-632-7455 jcarrozz@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Joseph Carrozza, Jr, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Pfizer
Investigators
Principal Investigator: Joseph Carrozza, Jr, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00344019     History of Changes
Other Study ID Numbers: 2006-P-000035/1
Study First Received: June 22, 2006
Last Updated: March 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Acute coronary syndrome
Percutaneous coronary intervention
Peri-procedure myocardial infarction

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014