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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Methodist Hospital
  • Wishard Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No atorvastatin

atorvastatin

Arm Description

Patients do not receive Atorvastatin prior to PCI in cath lab

Atorvastatin 80mg po given prior to PCI in cath lab

Outcomes

Primary Outcome Measures

Periprocedural Myonecrosis

Secondary Outcome Measures

Full Information

First Posted
September 17, 2009
Last Updated
August 24, 2015
Sponsor
Indiana University School of Medicine
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00979940
Brief Title
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
Acronym
ESTATE
Official Title
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Slower than anticipated enrollment for pilot study.
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
atorvastatin, clopidogrel, percutaneous intervention, periprocedural myonecrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No atorvastatin
Arm Type
No Intervention
Arm Description
Patients do not receive Atorvastatin prior to PCI in cath lab
Arm Title
atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin 80mg po given prior to PCI in cath lab
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80mg po given one time before PCI in cath lab.
Primary Outcome Measure Information:
Title
Periprocedural Myonecrosis
Time Frame
16-24 hours post PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Kreutz, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27350760
Citation
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.
Results Reference
derived

Learn more about this trial

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

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