RestenosisITALICNCT00780156
The ITALIC Study: Is There A LIfe for Drug-eluting Stents (DES) After Discontinuation of Clopidogrel
An observational study of Restenosis, run by French Cardiology Society at 1 site in France.
Trial summary
Background Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need for repeat revascularization procedures in patients who undergo PCI. The potential increased incidence of late stent thrombosis prompted cardiologists to prolong the use of dual anti-platelet therapy after the one… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis
- How many people
- 1,235 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Feb 2013
- Phase
- Observational
- 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
Study population: Patients after drug eluting stent implantation
Who may be able to join
- Male or female subject ≥ 18 years of age eligible for PCI with at least one drug eluting stent (name: Xience) implanted in all clinical situations excluding primary PCI for acute MI and treatment of the left main artery.
- Male or female subject ≥ 18 years of age eligible for PCI with at least one DES Xience.
- Patient not pre-treated with protein IIb/IIIa inhibitors (name: abxicimab or eptifibatide) during hospitalization
- Patient pre-treated with aspirin and clopidogrel before PCI
- ASA check at least 24 hours after the interruption of tirofiban
- The subject has given written informed and dated consent to participate in this study.
Who cannot join
- Subjects not able to give informed consent
- Prior implantation of DES
- Known platelets < 100 000/µl or known hemorrhagic diathesis
- Oral anticoagulation or treatment with abxicimab or eptifibatide during hospitalization
- ASA check less than 24 hours after the interruption of tirofiban
- Thrombolytic therapy within 4 days before ASA check
Show all 14Show fewer
- Contra-indication to aspirin or clopidogrel
- Recent major surgery < 6 weeks
- Evidence of an active gastrointestinal or urogenital bleeding
- Severe liver insufficiency
- Primary PCI for acute MI
- Left main PCI
- Any scheduled surgery during the year after enrollment
- Severe concomitant disease with life expectation < two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study
Background
Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need for repeat revascularization procedures in patients who undergo PCI. The potential increased incidence of late stent thrombosis prompted cardiologists to prolong the use of dual anti-platelet therapy after the one year duration recommended by the recent ESC guidelines. However, while the premise that the cardiologists should put all their patients on dual clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because of the potential increase of bleeding complications and of the healthcare cost increase. The recent possibility to monitor aspirin with bedside assays offers a real opportunity to compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen versus mono-aspirin regimen and to respond to the key question: can the investigators switch from dual to single antiplatelet therapy after six months in good aspirin responder patients ? Study National, multicenter, randomised prospective open group comparison of dual clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients treated with DES (name: XIENCE) implantation.
Read more
End point Primary: At 12 months: death, myocardial infarction, repeat urgent revascularization, stroke requiring a new hospitalisation and major bleedings.
Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation, of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding complications Participating centres: 60 french centers
Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45 months
- Conditions
- Restenosis
- Keywords
- Drug eluting stent, Dual antiplatelet therapy, bleeding, stent thrombosis, follow-up of the drug eluting stent
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RestenosisStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780156
- Sponsor's protocol ID
- 2008-004131-38
- Other IDs
- 2008-02, 2008
- Acronym
- ITALIC
- Status last verified
- Sep 2013
- First submitted
- 24 Oct 2008
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ITALIC Study Is There A LIfe for DES After Discontinuation of Clopidogrel : The ITALIC Study
- ClinicalTrials.gov ID
- NCT00780156
- Acronym / sponsor ID
- ITALIC / 2008-004131-38
- Conditions
- Restenosis
- Keywords
- Drug eluting stent, Dual antiplatelet therapy, bleeding, stent thrombosis, follow-up of the drug eluting stent
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Nov 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Oct 2008 (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.
Background
Drug-eluting stents (DES) have been extremely successful in reducing restenosis and the need for repeat revascularization procedures in patients who undergo PCI. The potential increased incidence of late stent thrombosis prompted cardiologists to prolong the use of dual anti-platelet therapy after the one year duration recommended by the recent ESC guidelines. However, while the premise that the cardiologists should put all their patients on dual clopidogrel-aspirin regimen for life sounds the easy way, it is an unrealistic goal because of the potential increase of bleeding complications and of the healthcare cost increase. The recent possibility to monitor aspirin with bedside assays offers a real opportunity to compare in good aspirin responder patients the two strategies: aspirin-clopidogrel regimen versus mono-aspirin regimen and to respond to the key question: can the investigators switch from dual to single antiplatelet therapy after six months in good aspirin responder patients ? Study National, multicenter, randomised prospective open group comparison of dual clopidogrel-ASA versus single ASA regimen after six months, in good ASA responder patients treated with DES (name: XIENCE) implantation.
End point Primary: At 12 months: death, myocardial infarction, repeat urgent revascularization, stroke requiring a new hospitalisation and major bleedings.
Secondary: Incidence at 24 and 36 months after drug eluting stent(name: XIENCE) implantation, of the same composite endpoint and incidence at 12, 24 and 36 months of minor bleeding complications Participating centres: 60 french centers
Date of study beginning: November 2008 Duration of inclusion: 9 months Duration of study: 45 months
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after drug eluting stent implantation
Key inclusion criteria (6 listed)
- Male or female subject ≥ 18 years of age eligible for PCI with at least one drug eluting stent (name: Xience) implanted in all clinical situations excluding primary PCI for acute MI and treatment of the left main artery.
- Male or female subject ≥ 18 years of age eligible for PCI with at least one DES Xience.
- Patient not pre-treated with protein IIb/IIIa inhibitors (name: abxicimab or eptifibatide) during hospitalization
- Patient pre-treated with aspirin and clopidogrel before PCI
- ASA check at least 24 hours after the interruption of tirofiban
Key exclusion criteria (14 listed)
- Subjects not able to give informed consent
- Prior implantation of DES
- Known platelets < 100 000/µl or known hemorrhagic diathesis
- Oral anticoagulation or treatment with abxicimab or eptifibatide during hospitalization
- ASA check less than 24 hours after the interruption of tirofiban
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restenosis, run by French Cardiology Society at 1 site in France.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Sep 2013. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: No more information will be given. No consequences on security and treatment of patients: standard therapy is already performed for all patients.). Results are not available in the source record.
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?
Incidence after XIENCE implantation of a composite endpoint of death, MI, repeat urgent revascularization, stroke requiring a new hospitalisation (time frame: 12 months). 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 30 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.