rgent surgery in patients with a recently implanted coronary drug-eluting stent: a phase II study of bridging antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel. - Tirofiban for urgent surgery aftercoronary stent

• Conditions: prevention of cardiac ischemic events in patients undergoing major or ocular surgery; MedDRA version: 9.1Level: SOCClassification code 10007541

• Registration Number: EUCTR2008-000561-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The study involves consecutive candidates for urgent major surgery or eye surgery in whom dual antiplatelet therapy cannot be withdrawn because they had received a drug eluting stent within the previous six months, or within the previous year if they are considered to be at higher risk of developing stent thrombosis because of stent implantation due to an acute coronary syndrome, diabetes, renal insufficiency, severe left ventricular dysfunction, malignancy, or in the left main coronary artery, the proximal segment of the left anterior descending artery (or equivalent in the case of a stent in an aortocoronary graft), or on a coronary bifurcation. The patients also are to be at such a risk of surgical bleeding that the surgeon would not operate while the patient was receiving clopidogrel.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excluded are patients with ongoing severe bleeding requiring emergency surgery (within 24 hours of hospital admission), those with thrombocytopenia <100.000 x 10-9/L, a stroke within the previous 30 days or a history of hemorrhagic stroke, intracranial disease or bleeding diathesis, severe hypertension, and those unwilling or unable to sign the informed consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study was to evaluate the efficacy and safety of a strategy of: a) strict cardiological monitoring; b) the discontinuation of clopidogrel five days before surgery and its replacement by a intravenous short-acting glycoprotein (GP) IIb/IIIa receptor blocker in the peri-operative period; and c) the resumption of dual oral antiplatelet therapy as soon as possible after surgery.;Secondary Objective: not applicable;Primary end point(s): The primary endpoint of the study is the composite of - cardiovascular death, - myocardial infarction, - the clinically required angiographic demonstration of an acute occlusion of the target lesion during index hospitalisation, and the need for surgical re-exploration because of bleeding.