Study Stopped
Slower than anticipated enrollment for pilot study.
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
ESTATE
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Nov 2008
Longer than P75 for not_applicable coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
September 22, 2015
CompletedSeptember 22, 2015
August 1, 2015
5.6 years
September 17, 2009
August 24, 2015
August 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Periprocedural Myonecrosis
16-24 hours post PCI
Study Arms (2)
No atorvastatin
NO INTERVENTIONPatients do not receive Atorvastatin prior to PCI in cath lab
atorvastatin
EXPERIMENTALAtorvastatin 80mg po given prior to PCI in cath lab
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing revascularization for significant coronary artery disease
- age range 21-85 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Methodist Hospital
Indianapolis, Indiana, 46202, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (1)
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.
PMID: 27350760DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rolf Kreutz
- Organization
- Indiana University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Kreutz, MD
Indiana University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 18, 2009
Study Start
November 1, 2008
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
September 22, 2015
Results First Posted
September 22, 2015
Record last verified: 2015-08