Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

Coronary Artery Disease Clinical Trial

— TIPS-2  

Official title:

Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01058057
• Other study ID #: KC EK-150/08
• Status: Recruiting
• Phase: Phase 3
• First received: January 27, 2010
• Last updated: February 2, 2010
• Start date: February 2008

Study information

• Verified date: January 2008
• Source: University Hospital, Motol
• Contact: David Zemanek, MD
• Phone: +420608921
• Email: zejada[@]seznam.cz
• 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) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Description:

This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.

Two arms:

1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)

2. control group (without atorvastatin pre-treatment, chronic statin treatment)

Primary endpoint:

Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)

Secondary endpoint:

Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Indication for percutaneous coronary intervention

• Informed consent

• Chronic statin therapy

Exclusion Criteria:

• Acute coronary syndrome in last 14 days

• Renal insufficiency (creatinine more 150 umol/l)

• Diseases severely limiting prognosis

• Previous participation in this study

• Chronic occlusion of the coronary artery, bypass intervention, left main intervention

• Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Study Design

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

Related Conditions & MeSH terms

• Coronary Angioplasty
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• atorvastatin
atorvastatin 80mg p.o. daily seven days before PCI

Locations

Country	Name	City	State
Czech Republic	Dpt. of Cardiology, University Hospital Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2. — View Citation

Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. Epub 2007 Jun 26. — View Citation

Veselka J, Zemánek D, Hájek P, Malý M, Adlová R, Martinkovicová L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periprocedural myocardial infarction measured by troponin I level		24 hours after PCI	No
Secondary	periprocedural myocardial infarction measured by creatinine kinase myocardial band		24 hours after PCI	No