Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study

Coronary Artery Disease Clinical Trial

— TIPS-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01378715
• Other study ID #: EK-134/10
• Status: Recruiting
• Phase: Phase 3
• First received: June 20, 2011
• Last updated: June 20, 2011
• Start date: June 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2011
• Source: University Hospital, Motol
• Contact: David Zemanek, MD
• Phone: +420608921566
• Email: zejada[@]seznam.cz
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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).

Locations

Country	Name	City	State
Czech Republic	1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen	Plzen
Czech Republic	Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol	Prague
Czech Republic	Dpt. of Cardiology, Hospital Podlesi	Trinec
Slovakia	Eastern Slovakia Institute of Cardiovascular Diseases	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Countries where clinical trial is conducted

Czech Republic,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periprocedural myocardial infarction during percutaneous coronary intervention	TnI concentration = 1.5 times the ULN	24 hours after PCI	No
Secondary	periprocedural myocardial infarction during percutaneous coronary intervention	TnI concentration = 3 times ULN	24 hours after PCI	No