Efficacy of Abciximab Bolus Only Regimen in Providing Inhibition of Platelet Action Over Time

NCT00929279 | Completed Phase 4 DMC

• 1 other identifier: FAS-07-I
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

In full responders to clopidogrel scheduled to undergo PCI for NSTEACS, the use of abciximab bolus only plus 600 mg clopidogrel loading dose will result in a non-inferior inhibition of platelet aggregation after 4 hours as measured by LTA (20micromol ADP) when compared with abciximab plus infusion and 300 mg clopidogrel loading dose.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; Abciximab; Bolus; Infusion; platelet inhibition; Non ST segment elevation acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• In responders to clopidogrel: Inhibition of platelet aggregation at peak 4h after administration of study drugs measured by LTA (stimulated with 20micromolar ADP)

  4 hours

Secondary Outcomes (4)

• In all patients treated and in the responders to clopidogrel: • Inhibition of platelet aggregation in the two study groups at time points different from 4 hours after abciximab bolus measured by LTA

  up to 24 hours

• MACE rate

  30 days

• Bleeding rates

  30 days

• Thrombocytopenia

  30 days

Study Arms (2)

Abciximab bolus plus infusion

ACTIVE COMPARATOR

Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen.

Drug: bolus+infusion

bolus only regimen

EXPERIMENTAL

Abciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose

Drug: abciximab bolus only regimen

Interventions

bolus+infusion DRUG

Abciximab bolus of 0.25mg /Kg, followed by a 12-h infusion 0.125 microg/Kg/min (to a maximum of 10 µg/min) and immediate clopidogrel at 300 mg loading regimen

Abciximab bolus plus infusion

abciximab bolus only regimen DRUG

Abciximab bolus of 0.25mg /Kg followed by placebo infusion and immediate clopidogrel at 600 mg loading dose

bolus only regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both of the following:
• Age \>18 years
• Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
• AND at least one of the following:
• An elevated cardiac troponin T level (≥0.015 μg per liter);
• The presence of ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV, or T-wave inversion of ≥0.2 mV in two contiguous leads)
• A documented history of coronary artery disease as evidenced by previous myocardial infarction, findings on previous coronary angiography, or a positive exercise test.

You may not qualify if:

• administration of fibrinolytic or any GP IIb IIIa inhibitors for the treatment of current AMI or within 1 month before it
• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Institue of Cardiology, University of Ferrara

Ferrara, Ferrara, 44100, Italy

Location

Related Publications (1)

• Valgimigli M, Campo G, Tebaldi M, Monti M, Gambetti S, Scalone A, Parrinello G, Ferrari R; Fabolus Synchro (facilitation through abciximab by dropping infusion Line in patients undergoing coronary stenting. Synergy with clopidogrel at high loading dose regimen) Investigators. Randomized, double-blind comparison of effects of abiciximab bolus only vs. on-label regimen on ex vivo inhibition of platelet aggregation in responders to clopidogrel undergoing coronary stenting. J Thromb Haemost. 2010 Sep;8(9):1903-11. doi: 10.1111/j.1538-7836.2010.03972.x.

  PMID: 20586923 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 29, 2009

Record last verified: 2009-06

Locations

IT (1)