Coronary Artery DiseasePhase 3TIPS-3NCT01378715
Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study
A Phase 3 study testing Rosuvastatin in people with Coronary Artery Disease, run by University Hospital, Motol at 4 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2010to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention
- signed informed consent
Who cannot join
- positive troponin I (≥ 1 ULN)
- previous inclusion in this study
- renal insufficiency (creatinine ≥ 200 umol/l)
- chronic treatment with rosuvastatin 40mg or more
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Czechia3 sites, 3 recruiting
- Recruiting
1st Medical Dept., Faculty of Medicine in Plzen, Charles University in Prague, University Hospital Plzen
Pilsen, 30100
Martin Matějovič, Prof., MD, MATEJOVIC@fnplzen.cz
Martin Matějovič, Prof., MD
- Recruiting
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
Prague, 15006
David Zemanek, MD, +420608921566, zejada@seznam.cz
Josef Veselka, Prof., MD
- Recruiting
Dpt. of Cardiology, Hospital Podlesi
Třinec, 73961
Alexandra Vodzinská, MD, +420558304404, avodzinska@volny.cz
Slovakia1 site, 1 recruiting
- Recruiting
Eastern Slovakia Institute of Cardiovascular Diseases
Košice, 04011
Monica Jankajova, MD, +4210557891011, mjankajova@gmail.com
About this study
Official title: Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3)
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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin
- Keywords
- coronary artery disease, percutaneous coronary intervention, statins, periprocedural myocardial infarction
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rosucard (Zentiva, Czech Republic)
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).
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | 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). Receives: Drug: Rosuvastatin |
| Control | No intervention | Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
periprocedural myocardial infarction during percutaneous coronary intervention
TnI concentration ≥ 1.5 times the ULN
Measured: 24 hours after PCI
Secondary outcomes (1)
periprocedural myocardial infarction during percutaneous coronary intervention
TnI concentration ≥ 3 times ULN
Measured: 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Investigators
- Josef Veselka, Prof., MD, Study chair, Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital MotolDavid Zemanek, MD, Study director, Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378715
- Sponsor's protocol ID
- EK-134/10
- Acronym
- TIPS-3
- Status last verified
- May 2011
- First submitted
- 20 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rosuvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study (TIPS-3)
- ClinicalTrials.gov ID
- NCT01378715
- Acronym / sponsor ID
- TIPS-3 / EK-134/10
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, statins, periprocedural myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: RosuvastatinPatients 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 intervention | –Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to no-pretreatment with rosuvastatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- significant coronary artery stenosis or occlusion indicated for percutaneous coronary intervention
- signed informed consent
Key exclusion criteria (4 listed)
- positive troponin I (≥ 1 ULN)
- previous inclusion in this study
- renal insufficiency (creatinine ≥ 200 umol/l)
- chronic treatment with rosuvastatin 40mg or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Rosucard (Zentiva, Czech Republic)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 |
Primary outcome
periprocedural myocardial infarction during percutaneous coronary intervention
Time frame: 24 hours after PCI
TnI concentration ≥ 1.5 times the ULN
1 secondary outcome
periprocedural myocardial infarction during percutaneous coronary intervention
Time frame: 24 hours after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Veselka, Prof., MD study chair
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
David Zemanek, MD study director
Dpt. of Cardiology, 2nd Medical School of Charles Universty and University Hospital Motol
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin in people with Coronary Artery Disease, run by University Hospital, Motol at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Zemanek, MD (+420608921566, zejada@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periprocedural myocardial infarction during percutaneous coronary intervention (time frame: 24 hours after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.