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)
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ClinicalTrials.gov Identifier: NCT01336348 |
Recruitment Status
:
Completed
First Posted
: April 15, 2011
Last Update Posted
: October 10, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ST Segment Elevation Myocardial Infarction | Drug: Prasugrel Drug: Tirofiban | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Multiple Oral and/or Intravenous Anti-platelet Strategies in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary PCI |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Experimental: prasugrel
Prasugrel 60 mg loading dose
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Drug: Prasugrel
60 mg loading dose given orally at presentation
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Active Comparator: Tirofiban
Tirofiban will be at a bolus only of 25uM or followed by 2 hour infusion
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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).
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- Percentage IPA after 20uMol/ADP at 30' will be superior in the tirofiban arm (as aggregate) versus prasugrel alone arm [ Time Frame: 30 minutes ]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.
- Percentage IPA at 15 minutes after ADP or TRAP induced platelet aggregation via traditional light transmission aggregometry. [ Time Frame: 15 minutes ]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 ]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 ]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 ]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 ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336348
Italy | |
Cardiology Unit | |
Ferrara, Italy, 44100 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marco Valgimigli, University of Ferrara |
ClinicalTrials.gov Identifier: | NCT01336348 History of Changes |
Other Study ID Numbers: |
FAB-PRO-I |
First Posted: | April 15, 2011 Key Record Dates |
Last Update Posted: | October 10, 2012 |
Last Verified: | October 2012 |
Keywords provided by Università degli Studi di Ferrara:
Prasugrel Tirofiban Clopidogrel glycoprotein IIa/IIIa inhibitors P2Y12 blockers |
Additional relevant MeSH terms:
Infarction Myocardial Infarction ST Elevation Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Tirofiban Prasugrel Hydrochloride Platelet Aggregation Inhibitors Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |