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Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI) (ESTATE)

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00979940
First received: September 17, 2009
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.


Condition Intervention
Coronary Artery Disease
 Drug: Atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • periprocedural myonecrosis [ Time Frame: 16-24 hours post PCI ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: November 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No atorvastatin
Patients do not receive Atorvastatin prior to PCI in cath lab
Experimental: atorvastatin
Atorvastatin 80mg po given prior to PCI in cath lab
 Drug: Atorvastatin
Atorvastatin 80mg po given one time before PCI in cath lab.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing revascularization for significant coronary artery disease
  • age range 21-85 years

Exclusion Criteria:

  • non-STEMI, STEMI
  • cancer
  • renal failure with creatinine>3.0mg/dl
  • liver cirrhosis
  • lymphoproliferative disorder
  • pregnancy
  • thrombocytopenia<150'000
  • coagulopathy (INR>1.5)
  • abnormal liver function tests
  • illicit drug use
  • history of statin intolerance
  • history of rhabdomyolysis
  • planned use of Glycoprotein IIb/IIIa inhibitors during PCI
  • current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979940

Contacts
Contact: Rolf Kreutz, MD rkreutz@iu.edu

Locations
United States, Indiana
Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Wishard Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Rolf Kreutz, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00979940     History of Changes
Other Study ID Numbers: 0712-15, 1470
Study First Received: September 17, 2009
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
atorvastatin
clopidogrel
percutaneous intervention
periprocedural myonecrosis

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive 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 May 21, 2013