Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention

Angioplasty, Transluminal, Percutaneous Coronary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610870
• Other study ID #: 2007-04-049
• Status: Completed
• Phase: N/A
• First received: January 27, 2008
• Last updated: March 2, 2011
• Start date: July 2007
• Est. completion date: August 2009

Study information

• Verified date: March 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary

Intervention

Drug:
• atorvastatin
atorvastatin 80mg/day before primary coronary intervention

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size by SPECT		between 5 and 14 days after acute myocardial infarction	No
Secondary	Myocardial infarct size measured by contrast-enhanced MRI		within 14 days after acute myocardial infarction	No
Secondary	Myocardial blush grade after the procedure		immediate after procedure	No
Secondary	complete ST resolution		at 60 minutes after the procedure	No
Secondary	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	No