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Effects of Atorvastatin on Myonecrosis

This study has been terminated.
(slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00344019
First Posted: June 26, 2006
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Donald Cutlip, Beth Israel Deaconess Medical Center
  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 Phase
Coronary Disease Drug: Placebo Oral Tablet Drug: Atorvastatin 80mg Other: Screening Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized trial of 80 mg atorvastatin vs. placebo pre PCI
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Donald Cutlip, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Peri-procedural Myonecrosis [ Time Frame: 24 hours ]
    As measured by troponin T (TnT), during percutaneous coronary intervention (PCI). TnT will be measured at 18-24 hours. Assuming a 40% event rate (elevation in TnT), this study powered to predict 30% relative reduction in TnT


Secondary Outcome Measures:
  • Other Biomarkers of Myocyte Injury (CK, CK-MB) [ Time Frame: 24 hours ]
    No data was analyzed due to small numbers. Collected data no longer available as retention period has passed

  • Inflammatory Markers (CRP) [ Time Frame: 24 hours ]
    No data was analyzed due to small numbers. Collected data no longer available as retention period has passed

  • Post PCI Growth of Tissue Level Perfusion Circumference and Brightness Using Digital Subtraction Angiography [ Time Frame: 24 hours ]
    No data was analyzed due to small numbers. Collected data no longer available as retention period has passed


Enrollment: 23
Actual Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: atorvastatin 80 mg
80 mg atorvastatin on average of 2-4 hours pre angio/PCI for ACS
Drug: Atorvastatin 80mg
atorvastatin 80 mg pre-angio/PCI
Other Name: lipitor
Other: Screening
Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
Placebo Comparator: placebo oral tablet
placebo on average of 2-4 hours pre angio/PCI for ACS
Drug: Placebo Oral Tablet
placebo pre-PCI for ACS
Other: Screening
Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)
No Intervention: Screening
Patients signed consent if willing to participate. Patients will continue onto randomization if appropriate per inc/exc (i.e. stent placement) otherwise screen fail

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344019


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Pfizer
Investigators
Principal Investigator: Joseph Carrozza, Jr, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Donald Cutlip, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00344019     History of Changes
Other Study ID Numbers: 2006P000035
First Submitted: June 22, 2006
First Posted: June 26, 2006
Results First Submitted: April 13, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plans to share data

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors