NCT00469326

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 coronary-artery-disease

Timeline
Completed

Started Apr 2005

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

Enrollment Period

3.7 years

First QC Date

May 3, 2007

Last Update Submit

January 26, 2009

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasepercutaneous coronary interventionatorvastatin

Outcome Measures

Primary Outcomes (1)

  • periprocedural myocardial infarction measured by troponin I level

    24 hours

Secondary Outcomes (1)

  • periprocedural myocardial infarction measured by creatine kinase myocardial band

    24 hours

Study Arms (2)

atorvastatin

ACTIVE COMPARATOR

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

Drug: Atorvastatin

control

NO INTERVENTION

PCI without atorvastatin pretreatment

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

two days 80mg atorvastatin pre-treatment before PCI

Also known as: Torvacard
atorvastatincontrol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, CardioVascular Center, University Hospital Motol

Prague, 150 18, Czechia

Location

Related Publications (4)

  • 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.

    PMID: 15277322BACKGROUND

  • 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.

    PMID: 15474697BACKGROUND

  • 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.

    PMID: 21349484DERIVED

  • 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: 19699335DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Josef Veselka, Prof., PhD.

    Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

April 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 27, 2009

Record last verified: 2009-01

Locations

CZ(1)