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 (FABOLUS PRO)

This study has been completed.
Sponsor:
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01336348
First received: April 13, 2011
Last updated: October 9, 2012
Last verified: October 2012

April 13, 2011
October 9, 2012
April 2010
June 2011   (final data collection date for primary outcome measure)
Percentage IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
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.
%IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01336348 on ClinicalTrials.gov Archive Site
  • Percentage IPA at 15 minutes after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • Clinical outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Death, Myocardial infarction, stroke and the need for target vessel revascularisation will be monitored up to 1 year
  • Percentage IPA at 1 hour after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • Percentage IPA at 2 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • Percentage IPA at 6 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • Percentage IPA at 18-24 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 18-24 hours ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • %IPA at various time points starting from 15 minutes up to 24 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Blood samples draen at 15', 30', 1H, 2H, 6H and 18-24H, 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) and 5 and 15 TRAP.
  • Clinical outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Death, Myocardial infarction, stroke and the need for target vessel revascularisation will be monitored up to 1 year
Not Provided
Not Provided
 
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
Comparison of Multiple Oral and/or Intravenous Anti-platelet Strategies in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary PCI

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ST Segment Elevation Myocardial Infarction
  • Drug: Prasugrel
    60 mg loading dose given orally at presentation
  • 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).
  • Experimental: prasugrel
    Prasugrel 60 mg loading dose
    Intervention: Drug: Prasugrel
  • Active Comparator: Tirofiban
    Tirofiban will be at a bolus only of 25uM or followed by 2 hour infusion
    Intervention: Drug: Tirofiban
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. PubMed PMID: 22440491.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01336348
FAB-PRO-I
No
Marco Valgimigli, University of Ferrara
Università degli Studi di Ferrara
Not Provided
Not Provided
Università degli Studi di Ferrara
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP