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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014