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

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ClinicalTrials.gov Identifier: NCT01058057
Recruitment Status : Unknown
Verified January 2008 by University Hospital, Motol.
Recruitment status was:  Recruiting
First Posted : January 28, 2010
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
University Hospital, Motol

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Angioplasty Drug: atorvastatin Phase 3

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
Study Start Date : February 2008
Estimated Primary Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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 Name: Torvacard



Primary Outcome Measures :
  1. periprocedural myocardial infarction measured by troponin I level [ Time Frame: 24 hours after PCI ]

Secondary Outcome Measures :
  1. periprocedural myocardial infarction measured by creatinine kinase myocardial band [ Time Frame: 24 hours after PCI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058057


Contacts
Contact: David Zemanek, MD +420608921 zejada@seznam.cz

Locations
Czech Republic
Dpt. of Cardiology, University Hospital Motol Recruiting
Prague, Czech Republic, 15018
Contact: David Zemanek, MD    +420608921566    zejada@seznam.cz   
Sponsors and Collaborators
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:
Responsible Party: Prof. Anna Sediva, MD, PhD, University Hospital Motol
ClinicalTrials.gov Identifier: NCT01058057     History of Changes
Other Study ID Numbers: KC EK-150/08
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: January 2008

Keywords provided by University Hospital, Motol:
atorvastatin
percutaneous coronary intervention
periprocedural myocardial infarction
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors