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

NCT01476020 | Unknown DMC

• 1 other identifier: 2011 08
• Study Type: observational
• Target: 1,240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• composite endpoint:death, myocardial infarction, repeat angioplasty due to the occurrence of restenosis, occurrence of stroke and major bleeding

  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

  36-month period

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilard, Martine: lead
• Clinical Research Organization and study management: collaborator
• Abbott Medical Devices: collaborator

Study Sites (1)

Department of cardiology

Brest, 29 609 Cedex, France

Location

Related Publications (1)

• 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.

  PMID: 25461690 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• martine Gilard, MD,PhD

  Brest University France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine Gilard, MD, PhD

CONTACT

+33 (0)2 98 34 75 05; martine.gilard@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2015
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

FR (1)