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NCT00979940 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— ESTATE  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00979940
Other study ID # 0712-15
Secondary ID 1470
Status Terminated
Phase N/A
First received September 17, 2009
Last updated August 24, 2015
Start date November 2008
Est. completion date August 2014

Study information
Verified date August 2015
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date August 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
Atorvastatin 80mg po given one time before PCI in cath lab.

Locations
Country Name City State
United States Methodist Hospital Indianapolis Indiana
United States Wishard Hospital Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
Indiana University School of Medicine National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Periprocedural Myonecrosis 16-24 hours post PCI No
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