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CompletedNCT00469326TIPSUpdated Jan 27, 2009

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

A Phase 3 interventional study of Atorvastatin in Coronary Artery Disease, sponsored by University Hospital, Motol. Completed at 1 site in Czech Republic. Per ClinicalTrials.gov, last updated 2009-01-27.

Sponsored by University Hospital, Motol · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • coronary artery disease
  • percutaneous coronary intervention
  • atorvastatin
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 200 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University Hospital, Motol is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • stable angina in last month
  • indication for percutaneous coronary intervention
  • informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    atorvastatin

    atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)

    Drug: Atorvastatin

  • No intervention
    control

    PCI without atorvastatin pretreatment

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    two days 80mg atorvastatin pre-treatment before PCI

    Also known as: Torvacard

06

What researchers measure

Primary outcomes

  1. periprocedural myocardial infarction measured by troponin I level

    Time frame: 24 hours

Secondary outcomes

  1. periprocedural myocardial infarction measured by creatine kinase myocardial band

    Time frame: 24 hours

07

Study locations

1 site
  • Department of Cardiology, CardioVascular Center, University Hospital Motol
    Prague, 150 18, Czech Republic
08

References and documents

Publications

  • 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. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26. PubMed 15277322 ↗
  • 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. doi: 10.1016/j.ehj.2004.07.017. PubMed 15474697 ↗
  • Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tomasov P, Tesar D. Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention. Am J Cardiol. 2011 May 1;107(9):1295-9. doi: 10.1016/j.amjcard.2010.12.040. Epub 2011 Feb 23. PubMed 21349484 ↗
  • 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. PubMed 19699335 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00469326
Lead sponsor
University Hospital, Motol
First posted
May 4, 2007
Start date
Apr 2005
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jan 27, 2009

Study contacts

Josef Veselka, Prof., PhD.
study chair · Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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