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Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI) (STATIN STEMI)

Primary Purpose

Myocardial Infarction, Angioplasty, Percutaneous Coronary

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Atorvastatin

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Coronary Angioplasty, Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient must be at least 18 years and 80 years of age.
The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion Criteria:

Patients to whom PCI can not be undergone within 12 hours from receiving the study drug
Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit
Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)
The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center)
The patients who might die of other disease than cardiac disease during the trial.

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose Atorvastatin 80 mg

Control

Arm Description

Administered Atorvastatin 80 mg before intervention

Administered Atorvastatin 10 mg before intervention

Outcomes

Primary Outcome Measures

To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization)

Secondary Outcome Measures

To evaluate the safety of high dose atorvastatin in STEMI - TIMI flow at before and after PCI - Myocardial blush grade after PCI - Procedural success (No reflow incidence) - MACE at 6 month - Periprocedural MI

Full Information

NCT ID

NCT00808717

First Posted

December 15, 2008

Last Updated

July 14, 2009

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT00808717

Brief Title

Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)

Acronym

STATIN STEMI

Official Title

Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in patients with STEMI that prior statin use may improve coronary blood flow after PCI in patients with AMI, possibly by its beneficial effects on microvascular function. But this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. Therefore, the investigators investigated whether acute high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Angioplasty, Percutaneous Coronary

Keywords

Myocardial Infarction, Coronary Angioplasty, Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High dose Atorvastatin 80 mg

Arm Type

Experimental

Arm Description

Administered Atorvastatin 80 mg before intervention

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Administered Atorvastatin 10 mg before intervention

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin 10 mg vs. 80 mg before intervention

Primary Outcome Measure Information:

Title

To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization)

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Time Frame

immediate, 30 days, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient must be at least 18 years and 80 years of age. The patient had the symptoms of acute myocardial infarction within 12 hours with ST segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB. The patient or guardian agrees to the study protocol and provides informed, written consent. Exclusion Criteria: Patients to whom PCI can not be undergone within 12 hours from receiving the study drug Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg The history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg) The history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center) The patients who might die of other disease than cardiac disease during the trial.

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

20298994

Citation

Kim JS, Kim J, Choi D, Lee CJ, Lee SH, Ko YG, Hong MK, Kim BK, Oh SJ, Jeon DW, Yang JY, Cho JR, Lee NH, Cho YH, Cho DK, Jang Y. Efficacy of high-dose atorvastatin loading before primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: the STATIN STEMI trial. JACC Cardiovasc Interv. 2010 Mar;3(3):332-9. doi: 10.1016/j.jcin.2009.11.021. Erratum In: JACC Cardiovasc Interv. 2012 Feb;5(2):248.

Results Reference

derived

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Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)

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