Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study
NCT ID: NCT01378715
Last Updated: 2011-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2010-06-30
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
Control
Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* signed informed consent
Exclusion Criteria
* previous inclusion in this study
* renal insufficiency (creatinine ≥ 200 umol/l)
* chronic treatment with rosuvastatin 40mg or more
18 Years
ALL
No
Sponsors
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University Hospital, Motol
OTHER
Responsible Party
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2nd Medical School of Charles University and University Hospital Motol
Principal Investigators
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Josef Veselka, Prof., MD
Role: STUDY_CHAIR
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
David Zemanek, MD
Role: STUDY_DIRECTOR
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Locations
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1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen
Pilsen, , Czechia
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Prague, , Czechia
Dpt. of Cardiology, Hospital Podlesi
Třinec, , Czechia
Eastern Slovakia Institute of Cardiovascular Diseases
Košice, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EK-134/10
Identifier Type: -
Identifier Source: org_study_id
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