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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)
This study has been completed.
Sponsor:
Università degli Studi di Ferrara
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
| ST Segment Elevation Myocardial Infarction | Drug: Prasugrel Drug: Tirofiban | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Università degli Studi di Ferrara:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: prasugrel
Prasugrel 60 mg loading dose
|
Drug: Prasugrel
60 mg loading dose given orally at presentation
|
|
Active Comparator: Tirofiban
Tirofiban will be at a bolus only of 25uM or followed by 2 hour infusion
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01336348
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336348
Locations
| Italy | |
| Cardiology Unit | |
| Ferrara, Italy, 44100 | |
Sponsors and Collaborators
Università degli Studi di Ferrara
More Information
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 |
| Study First Received: | April 13, 2011 |
| Last Updated: | October 9, 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 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 |
ClinicalTrials.gov processed this record on June 23, 2017