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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469326
First Posted: May 4, 2007
Last Update Posted: January 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Motol
  Purpose
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 Intervention Phase
Coronary Artery Disease Drug: Atorvastatin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Motol:

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

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

Enrollment: 200
Study Start Date: April 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: May 3, 2007
First Posted: May 4, 2007
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