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

NCT01058057 | Unknown Phase 3

• 1 other identifier: KC EK-150/08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Coronary Angioplasty

Keywords

atorvastatin; percutaneous coronary intervention; periprocedural myocardial infarction; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

• periprocedural myocardial infarction measured by troponin I level

  24 hours after PCI

Secondary Outcomes (1)

• periprocedural myocardial infarction measured by creatinine kinase myocardial band

  24 hours after PCI

Study Arms (1)

Atorvastatin

EXPERIMENTAL

Atorvastatin 80mg seven days pre-treatment before PCI

Drug: atorvastatin

Interventions

atorvastatin DRUG

atorvastatin 80mg p.o. daily seven days before PCI

Also known as: Torvacard

Atorvastatin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for percutaneous coronary intervention
• Informed consent
• Chronic statin therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

Dpt. of Cardiology, University Hospital Motol

Prague, 15018, Czechia

RECRUITING

Related Publications (3)

• Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova 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.

  PMID: 19699335 BACKGROUND

• 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.

  PMID: 19643320 BACKGROUND

• 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. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.

  PMID: 17826370 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• David Zemanek, MD

  Department of Cardiology, University Hospital Motol

  PRINCIPAL INVESTIGATOR

• Josef Veselka, Prof., MD., PhD.

  Department of Carldiology, University Hospital Motol

  STUDY CHAIR

Central Study Contacts

David Zemanek, MD

CONTACT

+420608921; zejada@seznam.cz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2008
• Primary Completion: June 1, 2010
• Last Updated: February 3, 2010

Record last verified: 2008-01

Locations

CZ (1)