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

February 2, 2010 updated by: University Hospital, Motol

Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. atorvastatin pre-treatment group (80mg atorvastatin for seven days)
  2. 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)

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 15018
        • Recruiting
        • Dpt. of Cardiology, University Hospital Motol
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin
Atorvastatin 80mg seven days pre-treatment before PCI
Drug: atorvastatin
atorvastatin 80mg p.o. daily seven days before PCI
Other Names:
  • Torvacard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
periprocedural myocardial infarction measured by troponin I level
Time Frame: 24 hours after PCI
24 hours after PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
periprocedural myocardial infarction measured by creatinine kinase myocardial band
Time Frame: 24 hours after PCI
24 hours after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Investigators

  • Principal Investigator: David Zemanek, MD, Department of Cardiology, University Hospital Motol
  • Study Chair: Josef Veselka, Prof., MD., PhD., Department of Carldiology, University Hospital Motol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC EK-150/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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