Coronary Artery DiseasePhase 3TIPSNCT00469326
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
A Phase 3 study testing Atorvastatin in people with Coronary Artery Disease, 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- 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
- Apr 2005to Dec 2008
- 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
- stable angina in last month
- indication for percutaneous coronary intervention
- informed consent
Who cannot join
- acute coronary syndrome in last 14 days
- renal insufficiency (creatinine more 150 µmol/l)
- diseases severely limiting prognosis
- immunosuppressive treatment
- statin one month before randomization
- occlusion of the coronary artery
- previous participation in this study
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Cardiology, CardioVascular Center, University Hospital Motol
Prague, 150 18
About this study
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Read the detailed description
Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.
- Conditions
- Coronary Artery Disease
- Being tested
- Atorvastatin
- Keywords
- coronary artery disease, percutaneous coronary intervention, atorvastatin
- 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
two days 80mg atorvastatin pre-treatment before PCI
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Active comparator | atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) Receives: Drug: Atorvastatin |
| control | No intervention | PCI without atorvastatin pretreatment 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
Secondary outcomes (1)
periprocedural myocardial infarction measured by creatine kinase myocardial band
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Investigators
- Josef Veselka, Prof., PhD., Study chair, Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469326
- Sponsor's protocol ID
- KC EK-361/05
- Acronym
- TIPS
- Status last verified
- Jan 2009
- First submitted
- 3 May 2007
- Last updated
- 27 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
PubMed 15277322Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8. doi: 10.1016/j.ehj.2004.07.017.
PubMed 15474697Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tomasov P, Tesar D. Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention. Am J Cardiol. 2011 May 1;107(9):1295-9. doi: 10.1016/j.amjcard.2010.12.040. Epub 2011 Feb 23.
PubMed 21349484Veselka 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 19699335
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. 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
- ClinicalTrials.gov ID
- NCT00469326
- Acronym / sponsor ID
- TIPS / KC EK-361/05
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, percutaneous coronary intervention, atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 May 2007 (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). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
Detailed description
Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Active comparator | Drug: Atorvastatinatorvastatin pre-treatment group (80mg atorvastatin two days before PCI) |
| control | No intervention | Drug: AtorvastatinPCI without atorvastatin pretreatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- stable angina in last month
- indication for percutaneous coronary intervention
- informed consent
Key exclusion criteria (7 listed)
- acute coronary syndrome in last 14 days
- renal insufficiency (creatinine more 150 µmol/l)
- diseases severely limiting prognosis
- immunosuppressive treatment
- statin one month before randomization
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: Torvacardtwo days 80mg atorvastatin pre-treatment before PCI | Drug | atorvastatin, control |
Primary outcome
periprocedural myocardial infarction measured by troponin I level
Time frame: 24 hours
1 secondary outcome
periprocedural myocardial infarction measured by creatine kinase myocardial band
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
- Background: PubMed 15277322Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.
- Background: PubMed 15474697Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8. doi: 10.1016/j.ehj.2004.07.017.
- Derived from this study: PubMed 21349484Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tomasov P, Tesar D. Effect of two-day atorvastatin pretreatment on long-term outcome of patients with stable angina pectoris undergoing elective percutaneous coronary intervention. Am J Cardiol. 2011 May 1;107(9):1295-9. doi: 10.1016/j.amjcard.2010.12.040. Epub 2011 Feb 23.
- Derived from this study: 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.
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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., PhD. study chair
Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic
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, 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 7 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: finished, as of the sponsor's last update on 27 Jan 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). 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 NCT00469326, which also lists 4 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 27 Jan 2009.