Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary artery disease, percutaneous coronary intervention, atorvastatin
Eligibility 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
Sites / Locations
- Department of Cardiology, CardioVascular Center, University Hospital Motol
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
atorvastatin
control
Arm Description
atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
PCI without atorvastatin pretreatment
Outcomes
Primary Outcome Measures
periprocedural myocardial infarction measured by troponin I level
Secondary Outcome Measures
periprocedural myocardial infarction measured by creatine kinase myocardial band
Full Information
NCT ID
NCT00469326
First Posted
May 3, 2007
Last Updated
January 26, 2009
Sponsor
University Hospital, Motol
1. Study Identification
Unique Protocol Identification Number
NCT00469326
Brief Title
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Acronym
TIPS
Official Title
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Motol
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, percutaneous coronary intervention, atorvastatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Description
atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
Arm Title
control
Arm Type
No Intervention
Arm Description
PCI without atorvastatin pretreatment
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Torvacard
Intervention Description
two days 80mg atorvastatin pre-treatment before PCI
Primary Outcome Measure Information:
Title
periprocedural myocardial infarction measured by troponin I level
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
periprocedural myocardial infarction measured by creatine kinase myocardial band
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Veselka, Prof., PhD.
Organizational Affiliation
Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiology, CardioVascular Center, University Hospital Motol
City
Prague
ZIP/Postal Code
150 18
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
15277322
Citation
Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
Results Reference
background
PubMed Identifier
15474697
Citation
Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8. doi: 10.1016/j.ehj.2004.07.017.
Results Reference
background
PubMed Identifier
21349484
Citation
Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tomasov P, Tesar D. Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention. Am J Cardiol. 2011 May 1;107(9):1295-9. doi: 10.1016/j.amjcard.2010.12.040. Epub 2011 Feb 23.
Results Reference
derived
PubMed Identifier
19699335
Citation
Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.
Results Reference
derived
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Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
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