Comparison of Antiplatelet Effect of Ticagrelor vs Tirofiban in Patients With Non-ST Elevation Acute Coronary Syndrome

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours

1. Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)

2. Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min

• both agents will be given on top of aspirin

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pusan National University Yangsan Hospital
• Collaborator: AstraZeneca
• Treatments: Ticagrelor; Tirofiban

Criteria

Inclusion Criteria:

• Patients with recent or current ischemic symptoms at the time of randomization will be eligible if 2 of the following criteria are met: ST-T change indicating ischemia; a positive test of biomarker indication myocardial necrosis; or one of several risk factors(age ≥60 years

• Previous myocardial infarction or coronary artery bypass grafting [CABG]

• Coronary artery disease with stenosis of ≥50% in at least two vessels

• Previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization

• Diabetes mellitus

• Peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area)

Exclusion Criteria:

1. Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current AMI

2. Major surgery or trauma within 30 days

3. Active bleeding

4. Previous stroke in the last six months

5. Oral anticoagulant therapy

6. Pre-existing thrombocytopenia

7. Vasculitis

8. Hypertensive retinopathy

9. Severe hepatic failure

10. Severe renal failure requiring hemodialysis

11. Documented allergy/intolerance or contraindication to tirofiban or P2Y12 inhibitor

12. Uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)

13. Limited life expectancy, e.g. neoplasms, others

14. Inability to obtain informed consent