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

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ClinicalTrials.gov Identifier: NCT00979940
Recruitment Status : Terminated (Slower than anticipated enrollment for pilot study.)
First Posted : September 18, 2009
Results First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Atorvastatin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
Study Start Date : November 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Periprocedural Myonecrosis [ Time Frame: 16-24 hours post PCI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979940


Locations
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46202
Wishard Hospital
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00979940     History of Changes
Other Study ID Numbers: 0712-15
1470
First Posted: September 18, 2009    Key Record Dates
Results First Posted: September 22, 2015
Last Update Posted: September 22, 2015
Last Verified: August 2015

Keywords provided by Indiana University ( Indiana University School of Medicine ):
atorvastatin
clopidogrel
percutaneous intervention
periprocedural myonecrosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors