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

NCT00808717 | Completed Phase 4 DMC

• 1 other identifier: 4-2007-0156
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (1)

• 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

  immediate, 30 days, 6 months

Study Arms (2)

High dose Atorvastatin 80 mg

EXPERIMENTAL

Administered Atorvastatin 80 mg before intervention

Drug: Atorvastatin

Control

ACTIVE COMPARATOR

Administered Atorvastatin 10 mg before intervention

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Atorvastatin 10 mg vs. 80 mg before intervention

Control; High dose Atorvastatin 80 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20298994 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Last Updated: July 15, 2009

Record last verified: 2009-07

Locations

KR (1)