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

Sponsored by:	Yonsei University
Information provided by:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00808717

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Angioplasty Percutaneous Coronary	Drug: Atorvastatin	Phase IV

MedlinePlus related topics: Angioplasty Heart Attack Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction

Further study details as provided by Yonsei University:

Primary Outcome Measures:

To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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 [ Time Frame: immediate, 30 days, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	July 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High dose Atorvastatin 80 mg: Experimental Administered Atorvastatin 80 mg before intervention	Drug: Atorvastatin Atorvastatin 10 mg vs. 80 mg before intervention
Control: Active Comparator Administered Atorvastatin 10 mg before intervention	Drug: Atorvastatin Atorvastatin 10 mg vs. 80 mg before intervention

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808717

Contacts

Contact: Donghoon Choi, MD, Ph D	02-2228-8460	cdhlyg@yuhs.ac
Contact: Jung Youn Bae, MS, RN	02-2228-8317	recath@yuhs.ac

Locations

Korea, Republic of
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Donghoon Choi, MD, Ph D 02-2228-8460 cdhlyg@yuhs.ac
Principal Investigator: Donghoon Choi, MD, Ph D
Sub-Investigator: Jung-Sun Kim, MD, Ph D
Principal Investigator: Sung Jin Oh, MD
Principal Investigator: Jung Rae Cho, MD
Principal Investigator: Deok-Kyu Cho, MD

Sponsors and Collaborators

Yonsei University

More Information

Responsible Party:	Cardiology, Yonsei University ( Donghoon Choi )
Study ID Numbers:	4-2007-0156
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808717
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Yonsei University:

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

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009