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 - Full Text View

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 Endpoint Classification: Pharmacokinetics Study 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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Prasugrel Tirofiban hydrochloride

U.S. FDA Resources

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 ] [ 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.

Secondary Outcome Measures:

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.


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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Università degli Studi di Ferrara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	Italy: Comitato Etico Emilia Romagna

Keywords provided by Università degli Studi di Ferrara:


Prasugrel Tirofiban Clopidogrel glycoprotein IIa/IIIa inhibitors P2Y12 blockers

Additional relevant MeSH terms:


Infarction Myocardial Infarction Cardiovascular Diseases Heart Diseases Ischemia Myocardial Ischemia Necrosis Pathologic Processes Vascular Diseases Prasugrel Tirofiban Cardiovascular Agents Fibrin Modulating Agents	Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Purinergic Agents Purinergic Antagonists Purinergic P2 Receptor Antagonists Purinergic P2Y Receptor Antagonists Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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)