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High-Dose Tirofiban with Enoxaparin in High-Risk PCI
NCT00790387Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2004
- Primary completion
- Dec 2005
- Countries
- 1
- Sponsor
- The Prince Charles Hospital
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- enoxaparin
- Conditions
- acute coronary syndrome (ACS)
01
Overview
Phase 4, randomised, open-label trial of enoxaparin in acute coronary syndrome (ACS) (2 arms), sponsored by The Prince Charles Hospital. Primary endpoint: Thrombus generation as determined by Prothrombin fragment 1+2 and D-dimer at 24 hours. Started Jun 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
High dose tirofiban and enoxaparin
Enoxaparin (0.75 mg/kg) + Tirofiban (25 mcg/kg bolus, 0.15 mcg/kg/min infusion)
Tirofiban and unfractionated heparin
UFH (70 U/kg bolus, ACT adjusted) + Tirofiban (25 mcg/kg bolus, 0.15 mcg/kg/min infusion)
03
Who it enrols
Patients with high-risk acute coronary syndrome undergoing PCI. Excludes patients with increased bleeding risk, recent trauma/surgery, severe hypertension (SBP > 180 mmHg), or renal impairment (CrCl < 30 mL/min).
04
Endpoints
Primary
Thrombus generation as determined by Prothrombin fragment 1+2 and D-dimer
Secondary
Panel of platelet activation markers: P selectin, MAC-1, PMAs, factor V/Va
Platelet inhibition as assessed by whole blood aggregometry
Inflammatory biomarkers: CD40L, vWF and CRP
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