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

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ClinicalTrials.gov Identifier: NCT00469326
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : January 27, 2009
Sponsor:
Information provided by:
University Hospital, Motol

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Atorvastatin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Study Start Date : April 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: atorvastatin
atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
Drug: Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI
Other Name: Torvacard
No Intervention: control
PCI without atorvastatin pretreatment
Drug: Atorvastatin
two days 80mg atorvastatin pre-treatment before PCI
Other Name: Torvacard



Primary Outcome Measures :
  1. periprocedural myocardial infarction measured by troponin I level [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. periprocedural myocardial infarction measured by creatine kinase myocardial band [ Time Frame: 24 hours ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469326


Locations
Czech Republic
Department of Cardiology, CardioVascular Center, University Hospital Motol
Prague, Czech Republic, 150 18
Sponsors and Collaborators
University Hospital, Motol
Investigators
Study Chair: Josef Veselka, Prof., PhD. Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Motol
ClinicalTrials.gov Identifier: NCT00469326     History of Changes
Other Study ID Numbers: KC EK-361/05
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: January 27, 2009
Last Verified: January 2009

Keywords provided by University Hospital, Motol:
coronary artery disease
percutaneous coronary intervention
atorvastatin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors