Coronary Artery DiseasePhase 3TIPS-2NCT01058057
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2
A Phase 3 study testing atorvastatin in people with Coronary Artery Disease and Coronary Angioplasty, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Coronary Angioplasty
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2008to Jun 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for percutaneous coronary intervention
- Informed consent
- Chronic statin therapy
Who cannot join
- Acute coronary syndrome in last 14 days
- Renal insufficiency (creatinine more 150 umol/l)
- Diseases severely limiting prognosis
- Previous participation in this study
- Chronic occlusion of the coronary artery, bypass intervention, left main intervention
- Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Dpt. of Cardiology, University Hospital Motol
Prague, 15018
David Zemanek, MD, +420608921566, zejada@seznam.cz
About this study
Official title: Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Read the detailed description
This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.
Two arms:
- atorvastatin pre-treatment group (80mg atorvastatin for seven days)
- control group (without atorvastatin pre-treatment, chronic statin treatment)
Primary endpoint:
Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)
Secondary endpoint:
Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)
- Conditions
- Coronary Artery Disease, Coronary Angioplasty
- Being tested
- atorvastatin
- Keywords
- atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- 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.
atorvastatinDrug
Also called Torvacard
atorvastatin 80mg p.o. daily seven days before PCI
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin 80mg seven days pre-treatment before PCI Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
periprocedural myocardial infarction measured by troponin I level
Measured: 24 hours after PCI
Secondary outcomes (1)
periprocedural myocardial infarction measured by creatinine kinase myocardial band
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 posted28 Jan 2010 (estimated)
- Study startFeb 2008
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Investigators
- David Zemanek, MD, Principal investigator, Department of Cardiology, University Hospital MotolJosef Veselka, Prof., MD., PhD., Study chair, Department of Carldiology, University Hospital Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058057
- Sponsor's protocol ID
- KC EK-150/08
- Acronym
- TIPS-2
- Status last verified
- Jan 2008
- First submitted
- 27 Jan 2010
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.
PubMed 19699335Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.
PubMed 19643320Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.
PubMed 17826370
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
- ClinicalTrials.gov ID
- NCT01058057
- Acronym / sponsor ID
- TIPS-2 / KC EK-150/08
- Conditions
- Coronary Artery Disease, Coronary Angioplasty
- Keywords
- atorvastatin, percutaneous coronary intervention, periprocedural myocardial infarction, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (estimated)
- First posted
- 28 Jan 2010 (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.
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Detailed description
This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.
Two arms:
- atorvastatin pre-treatment group (80mg atorvastatin for seven days)
- control group (without atorvastatin pre-treatment, chronic statin treatment)
Primary endpoint:
Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)
Secondary endpoint:
Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: atorvastatinAtorvastatin 80mg seven days pre-treatment before PCI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for percutaneous coronary intervention
- Informed consent
- Chronic statin therapy
Key exclusion criteria (6 listed)
- Acute coronary syndrome in last 14 days
- Renal insufficiency (creatinine more 150 umol/l)
- Diseases severely limiting prognosis
- Previous participation in this study
- Chronic occlusion of the coronary artery, bypass intervention, left main intervention
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 |
|---|---|---|
| atorvastatinAlso: Torvacardatorvastatin 80mg p.o. daily seven days before PCI | Drug | Atorvastatin |
Primary outcome
periprocedural myocardial infarction measured by troponin I level
Time frame: 24 hours after PCI
1 secondary outcome
periprocedural myocardial infarction measured by creatinine kinase myocardial band
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 3 Feb 2010.
- Background: PubMed 19699335Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.
- Background: PubMed 19643320Di Sciascio G, Patti G, Pasceri V, Gaspardone A, Colonna G, Montinaro A. Efficacy of atorvastatin reload in patients on chronic statin therapy undergoing percutaneous coronary intervention: results of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial. J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.
- Background: PubMed 17826370Mood GR, Bavry AA, Roukoz H, Bhatt DL. Meta-analysis of the role of statin therapy in reducing myocardial infarction following elective percutaneous coronary intervention. Am J Cardiol. 2007 Sep 15;100(6):919-23. doi: 10.1016/j.amjcard.2007.04.022. Epub 2007 Jun 26.
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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.
David Zemanek, MD principal investigator
Department of Cardiology, University Hospital Motol
Josef Veselka, Prof., MD., PhD. study chair
Department of Carldiology, University Hospital Motol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atorvastatin in people with Coronary Artery Disease and Coronary Angioplasty, run by University Hospital, Motol at 1 site in Czechia.
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 3 inclusion and 6 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 3 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 (+420608921, 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 measured by troponin I level (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?
On the ClinicalTrials.gov record for NCT01058057, which also lists 3 linked publications.
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 3 Feb 2010.