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
  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):

  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.

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:


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

ClinicalTrials.gov processed this record on October 16, 2014