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 )

Study Description

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 Design

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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

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

Periprocedural Myonecrosis [ Time Frame: 16-24 hours post PCI ]

Eligibility Criteria

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

Contacts and Locations

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

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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

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Principal Investigator:	Rolf Kreutz, MD	Indiana University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016.

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Responsible Party:	Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00979940
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:

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

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