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

NCT ID: NCT00808717

Last Updated: 2009-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

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.

Conditions

Myocardial Infarction; Angioplasty; Percutaneous Coronary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose Atorvastatin 80 mg

Administered Atorvastatin 80 mg before intervention

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin 10 mg vs. 80 mg before intervention

Control

Administered Atorvastatin 10 mg before intervention

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Atorvastatin 10 mg vs. 80 mg before intervention

Interventions

Atorvastatin

Atorvastatin 10 mg vs. 80 mg before intervention

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The patient must be at least 18 years and 80 years of age.

2. 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.

3. The patient or guardian agrees to the study protocol and provides informed, written consent.

Exclusion Criteria

1. Patients to whom PCI can not be undergone within 12 hours from receiving the study drug

2. Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg

3. 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

4. History of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit

5. Severe or malignant hypertension (= sitting SBP > 180 mmHg and/or sitting DBP > 105 mmHg)

6. 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)

7. The patients who might die of other disease than cardiac disease during the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Cardiology, Yonsei University

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 20298994 (View on PubMed)

Other Identifiers

4-2007-0156

Identifier Type: -

Identifier Source: org_study_id