NCT00979940TerminatedNot Applicable
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After PCI
Indiana University School of Medicine2 sites in 1 country60 target enrollmentStarted: November 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Periprocedural Myonecrosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing revascularization for significant coronary artery disease
- •age range 21-85 years
Exclusion Criteria
- •non-STEMI, STEMI
- •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
Arms & Interventions
atorvastatin
Experimental
Atorvastatin 80mg po given prior to PCI in cath lab
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
Periprocedural Myonecrosis
Time Frame: 16-24 hours post PCI
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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