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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: May 3, 2007
Last Updated: January 26, 2009
Health Authority: Czech Republic: State Institute for Drug Control

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014