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Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study (TIPS-3)

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ClinicalTrials.gov Identifier: NCT01378715
Recruitment Status : Unknown
Verified May 2011 by University Hospital, Motol.
Recruitment status was:  Recruiting
First Posted : June 22, 2011
Last Update Posted : June 22, 2011
Sponsor:
Information provided by:
University Hospital, Motol

Brief Summary:
The aim of this study is to determine whether a pre-treatment with high-dose statin (one day prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the occurrence of periprocedural myocardial infarction during percutaneous coronary intervention (PCI).

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

Detailed Description:

The aim of this study is to attest whether a short-term treatment with high-dose statin (one day prior and before intervention, rosuvastatin 20mg/day) can have a positive impact over the occurrence of periprocedural myocardial infarction during percutaneous coronary intervention (PCI). Patients with stable or unstable (with negative troponin) angina pectoris receiving statins (or not, except rosuvastatin 40mg a day) therapy referred for coronary angiography and subsequently PCI will be enrolled and randomized (ratio 1:1) to pre-treatment with rosuvastatin (20mg 12 hours prior + 20mg immediately before PCI - Rosuvastatin group), or immediate PCI (control group). Serum concentration of troponin I will be measured prior to, 12 hours and 24 hours after PCI.

Power of study (200 vs 200 pts; p1 = 0.2; p2 = 0.33; alfa = 0.05, n1 = 200, n2 = 200; power 0.84).

The primary end-point will be the TnI concentration ≥ 1.5 times the ULN. The secondary end-point witl be the TnI concentration ≥ 3 times ULN.

The Cox regression model will be used to identify the predictors of primary end-points (age, diabetes, smoking, symptomatic peripheral artery disease, statin pre-treatment, level of total cholesterol, pre-treatment with clopidogrel, multi-vessel disease, unstable angina, hs-CRP, therapy with beta-blockers, treatment of complex coronary lesion).

The patient included shall fulfill all the criteria: 1) significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention and 2) signed informed consent.

The criteria excluding the inclusion in the study are: 1) positive troponin I (≥ 1 ULN), 2) previous inclusion in this study, 3) renal insufficiency, 4) chronic treatment with rosuvastatin 40mg or more, and 5) disagreement to be included in this study.

This study will be multicenter. The Motol University Hospital will participate as the project coordinator.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3)
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rosuvastatin
Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to pre-treatment with rosuvastatin (20mg 12 hours prior + 20mg immediately prior PCI).
Drug: Rosuvastatin
Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to pre-treatment with rosuvastatin (20mg 12 hours prior + 20mg immediately prior PCI).
Other Name: Rosucard (Zentiva, Czech Republic)

No Intervention: Control
Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin.



Primary Outcome Measures :
  1. periprocedural myocardial infarction during percutaneous coronary intervention [ Time Frame: 24 hours after PCI ]
    TnI concentration ≥ 1.5 times the ULN


Secondary Outcome Measures :
  1. periprocedural myocardial infarction during percutaneous coronary intervention [ Time Frame: 24 hours after PCI ]
    TnI concentration ≥ 3 times ULN



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention
  • signed informed consent

Exclusion Criteria:

  • positive troponin I (≥ 1 ULN)
  • previous inclusion in this study
  • renal insufficiency (creatinine ≥ 200 umol/l)
  • chronic treatment with rosuvastatin 40mg or more

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): NCT01378715


Contacts
Contact: David Zemanek, MD +420608921566 zejada@seznam.cz
Contact: Josef Veselka, Prof., MD +420224434901 veselka.josef@seznam.cz

Locations
Czech Republic
1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen Recruiting
Plzen, Czech Republic, 30100
Contact: Martin Matějovič, Prof., MD       MATEJOVIC@fnplzen.cz   
Principal Investigator: Martin Matějovič, Prof., MD         
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol Recruiting
Prague, Czech Republic, 15006
Contact: David Zemanek, MD    +420608921566    zejada@seznam.cz   
Principal Investigator: Josef Veselka, Prof., MD         
Sub-Investigator: David Zemanek, MD         
Dpt. of Cardiology, Hospital Podlesi Recruiting
Třinec, Czech Republic, 73961
Contact: Alexandra Vodzinská, MD    +420558304404    avodzinska@volny.cz   
Slovakia
Eastern Slovakia Institute of Cardiovascular Diseases Recruiting
Kosice, Slovakia, 04011
Contact: Monica Jankajova, MD    +4210557891011    mjankajova@gmail.com   
Sponsors and Collaborators
University Hospital, Motol
Investigators
Study Chair: Josef Veselka, Prof., MD Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Study Director: David Zemanek, MD Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol

Responsible Party: Prof. Jan Trka, MD, PhD, 2nd Medical School of Charles University and University Hospital Motol
ClinicalTrials.gov Identifier: NCT01378715     History of Changes
Other Study ID Numbers: EK-134/10
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: May 2011

Keywords provided by University Hospital, Motol:
coronary artery disease
percutaneous coronary intervention
statins
periprocedural myocardial infarction

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