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

Restenosis Clinical Trial

— ITALICplus  

Official title:

Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01476020
• Other study ID #: 2011 08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 3, 2011
• Last updated: November 17, 2011
• Start date: November 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2011
• Source: Gilard, Martine
• Contact: Martine Gilard, MD, PhD
• Phone: +33 (0)2 98 34 75 05
• Email: martine.gilard[@]chu-brest.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthHungary: Research Ethics Medical CommitteePoland: Ethics CommitteeNorway: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1240
• Est. completion date: July 2015
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Restenosis

Locations

Country	Name	City	State
France	Department of cardiology	Brest

Sponsors (3)

Lead Sponsor	Collaborator
Gilard, Martine	Abbott Vascular, Clinical Research Organization and study management

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding		one year	Yes
Secondary	composite endpoint:Death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding and minor bleeding		36-month period	Yes