TIPS-3: Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study

Sponsor

University Hospital, Motol (Other)

Overall Status

Unknown status

CT.gov ID

NCT01378715

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Rosuvastatin	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	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). Other Names: Rosucard (Zentiva, Czech Republic)
No Intervention: Control Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin.

Arm

Intervention/Treatment

Active Comparator: 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).

Drug: Rosuvastatin

Other Names:

Rosucard (Zentiva, Czech Republic)

No Intervention: Control

Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin.

Outcome Measures

Primary Outcome Measures

periprocedural myocardial infarction during percutaneous coronary intervention [24 hours after PCI]
TnI concentration ≥ 1.5 times the ULN

Secondary Outcome Measures

periprocedural myocardial infarction during percutaneous coronary intervention [24 hours after PCI]
TnI concentration ≥ 3 times ULN

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen	Plzen	Czech Republic	30100
2	Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol	Prague	Czech Republic	15006
3	Dpt. of Cardiology, Hospital Podlesi	Třinec	Czech Republic	73961
4	Eastern Slovakia Institute of Cardiovascular Diseases	Kosice	Slovakia	04011

Sponsors and Collaborators

University Hospital, Motol

Investigators

Study Chair: Josef Veselka, Prof., MD, Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Study Director: David Zemanek, MD, Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol