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Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2 (TIPS-2)

Primary Purpose

Coronary Artery Disease, Coronary Angioplasty

Status
Unknown status
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
University Hospital, Motol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for percutaneous coronary intervention
  • Informed consent
  • Chronic statin therapy

Exclusion Criteria:

  • Acute coronary syndrome in last 14 days
  • Renal insufficiency (creatinine more 150 umol/l)
  • Diseases severely limiting prognosis
  • Previous participation in this study
  • Chronic occlusion of the coronary artery, bypass intervention, left main intervention
  • Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Sites / Locations

  • Dpt. of Cardiology, University Hospital MotolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin

Arm Description

Atorvastatin 80mg seven days pre-treatment before PCI

Outcomes

Primary Outcome Measures

periprocedural myocardial infarction measured by troponin I level

Secondary Outcome Measures

periprocedural myocardial infarction measured by creatinine kinase myocardial band

Full Information

First Posted
January 27, 2010
Last Updated
February 2, 2010
Sponsor
University Hospital, Motol
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1. Study Identification

Unique Protocol Identification Number
NCT01058057
Brief Title
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
Acronym
TIPS-2
Official Title
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)

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) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Detailed Description
This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy. Two arms: atorvastatin pre-treatment group (80mg atorvastatin for seven days) control group (without atorvastatin pre-treatment, chronic statin treatment) Primary endpoint: Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours) Secondary endpoint: Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Angioplasty
Keywords
atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin 80mg seven days pre-treatment before PCI
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Torvacard
Intervention Description
atorvastatin 80mg p.o. daily seven days before PCI
Primary Outcome Measure Information:
Title
periprocedural myocardial infarction measured by troponin I level
Time Frame
24 hours after PCI
Secondary Outcome Measure Information:
Title
periprocedural myocardial infarction measured by creatinine kinase myocardial band
Time Frame
24 hours after PCI

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for percutaneous coronary intervention Informed consent Chronic statin therapy Exclusion Criteria: Acute coronary syndrome in last 14 days Renal insufficiency (creatinine more 150 umol/l) Diseases severely limiting prognosis Previous participation in this study Chronic occlusion of the coronary artery, bypass intervention, left main intervention Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Zemanek, MD
Phone
+420608921
Email
zejada@seznam.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zemanek, MD
Organizational Affiliation
Department of Cardiology, University Hospital Motol
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josef Veselka, Prof., MD., PhD.
Organizational Affiliation
Department of Carldiology, University Hospital Motol
Official's Role
Study Chair
Facility Information:
Facility Name
Dpt. of Cardiology, University Hospital Motol
City
Prague
ZIP/Postal Code
15018
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zemanek, MD
Phone
+420608921566
Email
zejada@seznam.cz

12. IPD Sharing Statement

Citations:
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
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PubMed Identifier
19643320
Citation
Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.
Results Reference
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PubMed Identifier
17826370
Citation
Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.
Results Reference
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Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

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