Clinical trial NCT01378715: Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study
Official title: Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
percutaneous coronary intervention
statins
periprocedural myocardial infarction
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: periprocedural myocardial infarction during percutaneous coronary intervention
timeFrame: 24 hours after PCI
Secondary outcomes:
measure: periprocedural myocardial infarction during percutaneous coronary intervention
timeFrame: 24 hours after PCI
Other outcomes:
Locations:
city: Plzen
country: Czech Republic
facility: 1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen
city: Prague
country: Czech Republic
facility: Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
city: Třinec
country: Czech Republic
facility: Dpt. of Cardiology, Hospital Podlesi
city: Kosice
country: Slovakia
facility: Eastern Slovakia Institute of Cardiovascular Diseases
Study officials:
affiliation: Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
name: Josef Veselka, Prof., MD
role: STUDY_CHAIR
affiliation: Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
name: David Zemanek, MD
role: STUDY_DIRECTOR
References: