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

Indiana University School of Medicine

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00979940

1470

0712-15

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

No atorvastatin

No Intervention group

Description:

Patients do not receive Atorvastatin prior to PCI in cath lab

atorvastatin

Experimental group

Description:

Atorvastatin 80mg po given prior to PCI in cath lab

Treatment:

Drug: Atorvastatin