NCT00610870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

January 27, 2008

Last Update Submit

March 2, 2011

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Myocardial infarct sizeAtorvastatinSPECTHydroxymethylglutaryl-CoA Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarct size by SPECT

    between 5 and 14 days after acute myocardial infarction

Secondary Outcomes (4)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin group

Drug: atorvastatin

2

NO INTERVENTION

Control group

Interventions

atorvastatinDRUG

atorvastatin 80mg/day before primary coronary intervention

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Hyeon-Cheol Gwon, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2008

First Posted

February 8, 2008

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

August 1, 2009

Last Updated

March 3, 2011

Record last verified: 2011-03

Locations

KR(1)