Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

Coronary Artery Disease Clinical Trial

— TIPS  

Official title:

Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469326
• Other study ID #: KC EK-361/05
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2007
• Last updated: January 26, 2009
• Start date: April 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Description:

Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• stable angina in last month

• indication for percutaneous coronary intervention

• informed consent

Exclusion Criteria:

• acute coronary syndrome in last 14 days

• renal insufficiency (creatinine more 150 µmol/l)

• diseases severely limiting prognosis

• immunosuppressive treatment

• statin one month before randomization

• occlusion of the coronary artery

• previous participation in this study

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI

Locations

Country	Name	City	State
Czech Republic	Department of Cardiology, CardioVascular Center, University Hospital Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czech Republic, 

References & Publications (2)

Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8. — View Citation

Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. Epub 2004 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periprocedural myocardial infarction measured by troponin I level		24 hours
Secondary	periprocedural myocardial infarction measured by creatine kinase myocardial band		24 hours