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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014