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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)

Primary Purpose

ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Prasugrel
Tirofiban
Sponsored by
Università degli Studi di Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Segment Elevation Myocardial Infarction focused on measuring Prasugrel, Tirofiban, Clopidogrel, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prasugrel

Tirofiban

Arm Description

Prasugrel 60 mg loading dose

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2011
Last Updated
October 9, 2012
Sponsor
Università degli Studi di Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT01336348
Brief Title
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
Acronym
FABOLUS PRO
Official Title
Comparison of Multiple Oral and/or Intravenous Anti-platelet Strategies in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary PCI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Università degli Studi di Ferrara

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Segment Elevation Myocardial Infarction
Keywords
Prasugrel, Tirofiban, Clopidogrel, glycoprotein IIa/IIIa inhibitors, P2Y12 blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prasugrel
Arm Type
Experimental
Arm Description
Prasugrel 60 mg loading dose
Arm Title
Tirofiban
Arm Type
Active Comparator
Arm Description
Tirofiban will be at a bolus only of 25uM or followed by 2 hour infusion
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
60 mg loading dose given orally at presentation
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Intervention Description
Tirofiban will be given at high bolus dose only of bolus followed by 2 H infusion in a randomized manner (1:1 ratio).
Primary Outcome Measure Information:
Title
Percentage IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Percentage IPA at 15 minutes after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.
Description
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.
Time Frame
15 minutes
Title
Clinical outcomes
Description
Death, Myocardial infarction, stroke and the need for target vessel revascularisation will be monitored up to 1 year
Time Frame
1 year
Title
Percentage IPA at 1 hour after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.
Description
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.
Time Frame
1 hour
Title
Percentage IPA at 2 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.
Description
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.
Time Frame
2 hours
Title
Percentage IPA at 6 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.
Description
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.
Time Frame
6 hours
Title
Percentage IPA at 18-24 hours after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry.
Description
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.
Time Frame
18-24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cardiology Unit
City
Ferrara
ZIP/Postal Code
44100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22440491
Citation
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.
Results Reference
derived

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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

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