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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT00469326
First received: May 3, 2007
Last updated: January 26, 2009
Last verified: January 2009
History of Changes

May 3, 2007
January 26, 2009
April 2005
December 2008   (final data collection date for primary outcome measure)
periprocedural myocardial infarction measured by troponin I level [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT00469326 on ClinicalTrials.gov Archive Site
periprocedural myocardial infarction measured by creatine kinase myocardial band [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
 
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Artery Disease
Drug: Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI
Other Name: Torvacard
  • Active Comparator: atorvastatin
    atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
    Intervention: Drug: Atorvastatin
  • No Intervention: control
    PCI without atorvastatin pretreatment
    Intervention: Drug: Atorvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00469326
KC EK-361/05
No
University Hospital Motol
University Hospital, Motol
Not Provided
Study Chair: Josef Veselka, Prof., PhD. Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic
University Hospital, Motol
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP