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

NCT01336348 | Completed Phase 3

• 1 other identifier: FAB-PRO-I
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm

  Platelet aggregation (PA) will be performed as previously reported \[J Am Coll Cardiol 2006;48:2178-85\]. Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 10 min at 200 g, will be stimulated with 5 and 20 µmol/l adenosine 5'-diphosphate (ADP) (Alfa Wasserman, Bologna, Italia) and aggregation will be assessed using a AggRAM Advanced Modular System light transmittance aggregometer.

  30 minutes

Secondary Outcomes (6)

• Percentage IPA at 15 minutes after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.

  15 minutes

• Clinical outcomes

  1 year

• Percentage IPA at 1 hour after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.

  1 hour

• Percentage IPA at 2 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.

  2 hours

• Percentage IPA at 6 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.

  6 hours

Study Arms (2)

prasugrel

EXPERIMENTAL

Prasugrel 60 mg loading dose

Drug: Prasugrel

Tirofiban

ACTIVE COMPARATOR

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

Drug: Tirofiban

Interventions

Prasugrel DRUG

60 mg loading dose given orally at presentation

prasugrel

Tirofiban DRUG

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

Tirofiban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Cardiology Unit

Ferrara, Ferrara, 44100, Italy

Location

Related Publications (1)

• 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.

  PMID: 22440491 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride; Tirofiban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 15, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

IT (1)