Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00610870
First received: January 27, 2008
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Angioplasty, Transluminal, Percutaneous Coronary
Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Myocardial infarct size by SPECT [ Time Frame: between 5 and 14 days after acute myocardial infarction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial infarct size measured by contrast-enhanced MRI [ Time Frame: within 14 days after acute myocardial infarction ] [ Designated as safety issue: No ]
  • Myocardial blush grade after the procedure [ Time Frame: immediate after procedure ] [ Designated as safety issue: No ]
  • complete ST resolution [ Time Frame: at 60 minutes after the procedure ] [ Designated as safety issue: No ]
  • major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction) [ Time Frame: at 6 months after the procedure ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: July 2007
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Atorvastatin group
Drug: atorvastatin
atorvastatin 80mg/day before primary coronary intervention
No Intervention: 2
Control group

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610870

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: HC Gwon, MD,PhD / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00610870     History of Changes
Other Study ID Numbers: 2007-04-049
Study First Received: January 27, 2008
Last Updated: March 2, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Myocardial infarct size
Atorvastatin
SPECT
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014