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

August 24, 2015 updated by: Indiana University School of Medicine

Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Periprocedural Myonecrosis
Time Frame: 16-24 hours post PCI
16-24 hours post PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

National Center for Research Resources (NCRR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0712-15
  • 1470

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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