Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study
TIPS-3
1 other identifier
interventional
400
2 countries
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Jun 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJune 22, 2011
May 1, 2011
2 years
June 20, 2011
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
periprocedural myocardial infarction during percutaneous coronary intervention
TnI concentration ≥ 1.5 times the ULN
24 hours after PCI
Secondary Outcomes (1)
periprocedural myocardial infarction during percutaneous coronary intervention
24 hours after PCI
Study Arms (2)
Rosuvastatin
ACTIVE COMPARATORPatients 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).
Control
NO INTERVENTIONPatients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin.
Interventions
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).
Eligibility Criteria
You may qualify if:
- significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention
- signed informed consent
You may not qualify if:
- positive troponin I (≥ 1 ULN)
- renal insufficiency (creatinine ≥ 200 umol/l)
- chronic treatment with rosuvastatin 40mg or more
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen
Pilsen, 30100, Czechia
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Prague, 15006, Czechia
Dpt. of Cardiology, Hospital Podlesi
Třinec, 73961, Czechia
Eastern Slovakia Institute of Cardiovascular Diseases
Košice, 04011, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 22, 2011
Study Start
June 1, 2010
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
June 22, 2011
Record last verified: 2011-05