Facilitation Through Aggrastat By drOpping or Shortening Infusion Line in Patients With ST-segment Elevation Myocardial Infarction Compared to or on Top of PRasugrel Loading dOse

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-centre, open-label prospective randomized pharmacodynamic investigation of 2 antiplatelet regimens in patients undergoing coronary intervention for ST segment elevation myocardial infarction(STEMI):

1. Tirofiban bolus only or bolus followed by 2 hour infusion on top of 600 mg clopidogrel or 60 mg prasugrel.

2. Prasugrel given at 60 mg.

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

Details

• Lead Sponsor: Università degli Studi di Ferrara
• Treatments: Prasugrel Hydrochloride; Tirofiban

Criteria

Inclusion Criteria:

• Chest pain for >30 min with an electrocardiographic ST-segment elevation more than 1 mm in two or more contiguous electrocardiogram (ECG) leads, or with a new left bundle-branch block, and admission either within 12 h of symptom onset or between 12 and 24 h after onset with evidence of continuing ischemia

Exclusion Criteria:

• Administration of fibrinolytic or any GP IIbIIIa inhibitors for the treatment of current AMI or within 1 month before history of bleeding diathesis

• Known sensitivity to abciximab, to any component of the product or to murine monoclonal antibodies

• Major surgery or trauma within 30 days

• Active bleeding

• Previous stroke in the last six months

• Oral anticoagulant therapy

• Pre-existing thrombocytopenia

• Vasculitis

• Hypertensive retinopathy

• Severe hepatic failure

• Severe renal failure requiring haemodialysis

• Documented allergy/intolerance or contraindication to clopidogrel or inability to assume clopidogrel on a consecutive daily basis for a minimum of 30 days, or to heparin or aspirin

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

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

• Inability to obtain informed consent