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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by Gilard, Martine
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
  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:


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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: France: Committee for the Protection of Personnes
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Hungary: Research Ethics Medical Committee
Poland: Ethics Committee
Norway: Ethics Committee

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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014