Status:
COMPLETED
Tirofiban and Enoxaparin in High Risk Coronary Intervention
Lead Sponsor:
The Prince Charles Hospital
Collaborating Sponsors:
Sanofi
Merck Sharp & Dohme LLC
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 o...
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 wit...
Eligibility Criteria
Inclusion
- Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent
- Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI
- Experienced ischaemic pain at rest
- Lasting 10 minutes and occurring within 7 days before enrollment
- As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (\< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads
- Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference -High-risk angiographic features that included intraluminal filling defect, angiographically visible thrombus eccentric lesion, type, location in a proximal major vessel and thrombolysis in myocardial infarction (TIMI) flow of II or less
Exclusion
- Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm;
- Recent (\<1 month) trauma or major surgery (including bypass surgery);
- Active bleeding
- Unexplained clinically significant bleeding, thrombocytopenia (platelet count \< 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy
- Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure \> 180 mm Hg despite treatment)
- Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, -Thrombolytic therapy within preceding 24 hours
- Receiving antiIIb/IIIa therapy
- Creatinine clearance of \<30 mL/min
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00790387
Start Date
June 1 2004
End Date
December 1 2006
Last Update
March 24 2010
Active Locations (1)
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1
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032