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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00808717
First received: December 15, 2008
Last updated: July 14, 2009
Last verified: July 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of High Dose Atorvastatin Loading in ST Elevation Myocardial Infarction

Resource links provided by NLM:


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
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose Atorvastatin 80 mg
Administered Atorvastatin 80 mg before intervention
Drug: Atorvastatin
Atorvastatin 10 mg vs. 80 mg before intervention
Active Comparator: Control
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:

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

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donghoon Choi, Cardiology, Yonsei University
ClinicalTrials.gov Identifier: NCT00808717     History of Changes
Other Study ID Numbers: 4-2007-0156
Study First Received: December 15, 2008
Last Updated: July 14, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
Myocardial Infarction
Coronary Angioplasty
Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014