Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br>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<br>* 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).<br>* Other names: Rosucard (Zentiva, Czech Republic);|
| No Intervention: Control<br>Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction during percutaneous coronary intervention | TnI concentration ≥ 1.5 times the ULN | 24 hours after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction during percutaneous coronary intervention | TnI concentration ≥ 3 times ULN | 24 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, statins, percutaneous coronary intervention, periprocedural myocardial infarction