RestenosisITALICplusNCT01476020
Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel
An observational study of Restenosis, run by Gilard, Martine at 1 site in France.
Trial summary
The ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis
- How many people
- 1,240 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Jul 2015
- 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: Subjects are selected from the general population needing Percutaneous Coronary Interventions (PCI).
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.
France1 site
Department of cardiology
Brest, 29 609 Cedex
martine Gilard, MD, PhD, +33 (0)2 98 34 75 05, martine.gilard@chu-brest.fr
Martine Gilard, MD, PhD
About this study
Official title: Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial
The ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials.
Read the detailed description
The use of drug-eluting stents has resulted in a significant reduction in the restenosis rate and in the need for repeat angioplasty of the stented lesion. However, the occurrence of late stent thrombosis has resulted in an increase in the duration of dual antiplatelet treatment.
According to the guidelines of the ESC, the current recommended duration of dual antiplatelet treatment is 12 months.
A relationship has been demonstrated between the occurrence of late stent thrombosis and aspirin resistance.
Furthermore, dual anti-platelet treatment is associated with an increase in bleeding, the severity of which has been well documented. In addition, the patients involved, and especially those over 70, have significant co-morbidities often requiring extra-cardiac surgery which cannot easily be carried out in patients on dual antiplatelet treatment or clopidogrel.
The objective of this study is to determine whether, after a period of 6 months following Drug eluting stent (DES) implantation in patients regarded as sensitive to aspirin, dual antiplatelet therapy may be replaced by aspirin alone.
The original Italic Trial is a multicenter, randomized study evaluating the non-inferiority of aspirin as a single treatment versus dual antiplatelet therapy with clopidogrel and aspirin 6 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis.
- Conditions
- Restenosis
- Keywords
- Drug eluting stent, Dual antiplatelet therapy, bleeding, stent thrombosis, follow-up of the drug eluting stent
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no clopidogrel 6 months after DES | Patients with a single treatment antiplatelet therapy (aspirin) 6 months after drug-eluting stent implantation (Xience V Abbott company), including a 12-, 24- and 36-month follow-up analysis. | |
| 2 antiplatelet therapy 2 years after DES | patients with dual antiplatelet therapy with clopidogrel and aspirin 24 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding
Measured: one year
Secondary outcomes (1)
composite endpoint:Death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding and minor bleeding
Measured: 36-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilard, Martine
- Collaborators
- Clinical Research Organization and study management, Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- martine Gilard, MD,PhD, Principal investigator, Brest University France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476020
- Sponsor's protocol ID
- 2011 08
- Acronym
- ITALICplus
- Status last verified
- Nov 2011
- First submitted
- 3 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gilard M, Barragan P, Noryani AAL, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K, Benamer H, Kiss RG, Ungi I, Boschat J, Morice MC. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol. 2015 Mar 3;65(8):777-786. doi: 10.1016/j.jacc.2014.11.008. Epub 2014 Nov 16.
PubMed 25461690
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial
- ClinicalTrials.gov ID
- NCT01476020
- Acronym / sponsor ID
- ITALICplus / 2011 08
- Conditions
- Restenosis
- Keywords
- Drug eluting stent, Dual antiplatelet therapy, bleeding, stent thrombosis, follow-up of the drug eluting stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,240 participants (estimated)
- Lead sponsor
- Gilard, Martine
- Collaborators
- Clinical Research Organization and study management, Abbott Medical Devices
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 22 Nov 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 ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials.
Detailed description
The use of drug-eluting stents has resulted in a significant reduction in the restenosis rate and in the need for repeat angioplasty of the stented lesion. However, the occurrence of late stent thrombosis has resulted in an increase in the duration of dual antiplatelet treatment.
According to the guidelines of the ESC, the current recommended duration of dual antiplatelet treatment is 12 months.
A relationship has been demonstrated between the occurrence of late stent thrombosis and aspirin resistance.
Furthermore, dual anti-platelet treatment is associated with an increase in bleeding, the severity of which has been well documented. In addition, the patients involved, and especially those over 70, have significant co-morbidities often requiring extra-cardiac surgery which cannot easily be carried out in patients on dual antiplatelet treatment or clopidogrel.
The objective of this study is to determine whether, after a period of 6 months following Drug eluting stent (DES) implantation in patients regarded as sensitive to aspirin, dual antiplatelet therapy may be replaced by aspirin alone.
The original Italic Trial is a multicenter, randomized study evaluating the non-inferiority of aspirin as a single treatment versus dual antiplatelet therapy with clopidogrel and aspirin 6 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no clopidogrel 6 months after DES | – | –Patients with a single treatment antiplatelet therapy (aspirin) 6 months after drug-eluting stent implantation (Xience V Abbott company), including a 12-, 24- and 36-month follow-up analysis. |
| 2 antiplatelet therapy 2 years after DES | – | –patients with dual antiplatelet therapy with clopidogrel and aspirin 24 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are selected from the general population needing Percutaneous Coronary Interventions (PCI).
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
composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding
Time frame: one year
1 secondary outcome
composite endpoint:Death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding and minor bleeding
Time frame: 36-month period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Derived from this study: PubMed 25461690Gilard M, Barragan P, Noryani AAL, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K, Benamer H, Kiss RG, Ungi I, Boschat J, Morice MC. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol. 2015 Mar 3;65(8):777-786. doi: 10.1016/j.jacc.2014.11.008. Epub 2014 Nov 16.
Related trials for Restenosis
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
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.
martine Gilard, MD,PhD principal investigator
Brest University France
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 Gilard, Martine 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: status not confirmed, as of the sponsor's last update on 22 Nov 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine Gilard, MD, PhD (+33 (0)2 98 34 75 05, martine.gilard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding (time frame: one year). 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 NCT01476020, which also lists 1 linked publication.
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 Nov 2011.