Coronary Artery Disease Clinical Trial
Official title:
Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3)
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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