Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel (ITALICplus)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2011 by Gilard, Martine.
Recruitment status was: Not yet recruiting

Sponsor:

Collaborators:

Clinical Research Organization and study management

Abbott Vascular

Information provided by (Responsible Party):

Gilard, Martine

ClinicalTrials.gov Identifier:

NCT01476020

First received: November 3, 2011

Last updated: November 17, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition	Phase
Restenosis	Phase 3


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial

Resource links provided by NLM:

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Gilard, Martine:

Primary Outcome Measures:

composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding [ Time Frame: one year ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	1240
Study Start Date:	November 2011
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects are selected from the general population needing Percutaneous Coronary Interventions (PCI).

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476020

Contacts


Contact: Martine Gilard, MD, PhD	+33 (0)2 98 34 75 05	martine.gilard@chu-brest.fr

Locations


France
Department of cardiology	Not yet recruiting
Brest, France, 29 609 Cedex
Contact: martine Gilard, MD, PhD +33 (0)2 98 34 75 05 martine.gilard@chu-brest.fr
Principal Investigator: Martine Gilard, MD, PhD

Sponsors and Collaborators

Gilard, Martine

Clinical Research Organization and study management

Abbott Vascular

Investigators


Principal Investigator:	martine Gilard, MD,PhD	Brest University France

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gilard M, Barragan P, Noryani AA, 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):777-86. doi: 10.1016/j.jacc.2014.11.008. Epub 2014 Nov 16.


Responsible Party:	Gilard, Martine
ClinicalTrials.gov Identifier:	NCT01476020 History of Changes
Other Study ID Numbers:	2011 08
Study First Received:	November 3, 2011
Last Updated:	November 17, 2011

Keywords provided by Gilard, Martine:


Drug eluting stent Dual antiplatelet therapy bleeding stent thrombosis follow-up of the drug eluting stent

Additional relevant MeSH terms:


Clopidogrel Ticlopidine Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017

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