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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01476020
Other study ID # 2011 08
Secondary ID
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


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
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