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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University Hospital, Motol.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT01058057
First received: January 27, 2010
Last updated: February 2, 2010
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
Coronary Angioplasty
 Drug: atorvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Motol:

Primary Outcome Measures:
  • periprocedural myocardial infarction measured by troponin I level [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • periprocedural myocardial infarction measured by creatinine kinase myocardial band [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Atorvastatin 80mg seven days pre-treatment before PCI
 Drug: atorvastatin
atorvastatin 80mg p.o. daily seven days before PCI
Other Name: Torvacard

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)

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 27, 2010
Last Updated: February 2, 2010
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on May 21, 2013