NCT00790387

Tirofiban and Enoxaparin in High Risk Coronary Intervention

High Bolus Dose Tirofiban and Enoxaparin Provides Reduced Thrombin Generation and Inflammatory Markers in Patients With High Risk Undergoing Percutaneous Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Prince Charles Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Patients undergoing coronary angioplasty are frequently treated with new drugs that stop blood platelets working and so improve the success of the procedure. Individual patients may vary in the dose of the drug required. New platelet tests have been developed which can be performed near the patient and possibly immediately tell the doctor the degree of platelet inhibition achieved so that the dose can be adjusted accordingly. This study aims to investigate if these platelet tests indicate if new anticoagulants are more effective at inhibiting platelet function than the traditional anticoagulants. The study will demonstrate if these newer drugs improve blood flow through the heart muscle and thereby provide better long term outcomes for patients undergoing percutaneous intervention.

Detailed description

Objectives: The study assessed the benefit of high bolus dose tirofiban with enoxaparin compared to unfractionated heparin. Introduction: The benefit of the use of glycoprotein IIb/IIa inhibitors with low molecular weight heparins in high risk patients undergoing percutaneous intervention (PCI) over traditional unfractionated heparin (UFH) is debated. Methods; The study is a prospective single center open-label trial of patients with high-risk acute coronary syndrome treated with PCI who were randomised to anticoagulation with UFH or enoxaparin with 'high dose' (25 mcg/kg bolus) tirofiban This study measured a panel of platelet activation markers, inflammatory biomarkers and thrombus generation between the two groups.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Enoxaparin	Enoxaparin was administered at the commencement of PCI at a dose of 0.75 mg/kg
DRUG	Tirofiban
DRUG	unfractionated heparin

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-12-01
• Completion: 2006-12-01
• First posted: 2008-11-13
• Last updated: 2010-03-24

Locations

1 site across 1 country: Australia