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

NCT ID: NCT01336348

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-06-30

Brief 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.

Detailed Description

Primary hypothesis: Percentage IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm Percentage IPA at 30' after 20uMol/ADP 90%±15 and 80%±15 in the tirofiban and prasugrel alone arm, respectively. For a power of 90% and an alpha error set at 5%, 50 patients per group have to be recruited.

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

Prasugrel; Tirofiban; Clopidogrel; glycoprotein IIa/IIIa inhibitors; P2Y12 blockers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

prasugrel

Prasugrel 60 mg loading dose

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: DRUG

60 mg loading dose given orally at presentation

Tirofiban

Tirofiban will be at a bolus only of 25uM or followed by 2 hour infusion

Group Type: ACTIVE_COMPARATOR

Tirofiban

Intervention Type: DRUG

Tirofiban will be given at high bolus dose only of bolus followed by 2 H infusion in a randomized manner (1:1 ratio).

Interventions

Prasugrel

60 mg loading dose given orally at presentation

Intervention Type: DRUG

Tirofiban

Tirofiban will be given at high bolus dose only of bolus followed by 2 H infusion in a randomized manner (1:1 ratio).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

University of Ferrara

Locations

Cardiology Unit

Ferrara, Ferrara, Italy

Countries

Italy

References

Valgimigli M, Tebaldi M, Campo G, Gambetti S, Bristot L, Monti M, Parrinello G, Ferrari R; FABOLUS PRO Investigators. Prasugrel versus tirofiban bolus with or without short post-bolus infusion with or without concomitant prasugrel administration in patients with myocardial infarction undergoing coronary stenting: the FABOLUS PRO (Facilitation through Aggrastat By drOpping or shortening Infusion Line in patients with ST-segment elevation myocardial infarction compared to or on top of PRasugrel given at loading dOse) trial. JACC Cardiovasc Interv. 2012 Mar;5(3):268-77. doi: 10.1016/j.jcin.2012.01.006.

Reference Type: DERIVED

PMID: 22440491 (View on PubMed)

Other Identifiers

FAB-PRO-I

Identifier Type: -

Identifier Source: org_study_id