Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention

Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.

Study Overview

• Status: Completed
• Conditions: Angioplasty, Transluminal, Percutaneous Coronary
• Intervention / Treatment: Drug: atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
• ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage

Exclusion Criteria:

• Cardiogenic shock
• History of myocardial infarction
• Chronic liver disease
• Previous or current statin use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Atorvastatin group	Drug: atorvastatin; atorvastatin 80mg/day before primary coronary intervention
NO_INTERVENTION: 2; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarct size by SPECT	between 5 and 14 days after acute myocardial infarction

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarct size measured by contrast-enhanced MRI	within 14 days after acute myocardial infarction
Myocardial blush grade after the procedure	immediate after procedure
complete ST resolution	at 60 minutes after the procedure
major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction)	at 6 months after the procedure

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: January 27, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (ESTIMATE): February 8, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2011
• Last Update Submitted That Met QC Criteria: March 2, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Atorvastatin; SPECT; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Myocardial infarct size
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2007-04-049