Randomized Comparison of Abciximab Plus Heparin With Bivalirudin in Acute Coronary Syndrome
Condition: Myocardial Infarction; Coronary Disease
MeSH terms: Myocardial Infarction; Coronary Disease; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine which of these anti-clotting medications, abciximab
      plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and
      bleeding complications in patients suffering from a heart attack and undergoing coronary
      intervention.
    

Detailed description: 
      Non-ST elevation myocardial infarction (NSTEMI) is associated with an increased risk of death
      and is a major reason for hospital admissions. Most frequently, the sequence of events that
      leads to NSTEMI is characterized by a disrupted atherosclerotic plaque, platelet activation
      and aggregation, thrombus formation and microembolizations. Patients with NSTEMI are treated
      with an early invasive strategy and there is intensive work in progress to define the optimal
      antithrombotic therapy to be used in adjunct to percutaneous coronary intervention (PCI) in
      these patients. Bivalirudin, a direct thrombin inhibitor, and the glycoprotein IIb/IIIa
      inhibitor (GPI) abciximab have been in the focus of recent trials in patients with acute
      coronary syndrome (ACS). In a recent randomized, open-label trial (ACUITY trial), patients
      with the suspicion of ACS on the basis of the type of anginal symptoms, ST-segment
      displacement, elevated biomarkers or several risk indicators were randomized to receive
      bivalirudin alone with bail-out GPIs, bivalirudin plus GPIs, or heparin/low-molecular weight
      heparin plus a GPI. The GPIs most frequently used were eptifibatide and tirofiban. Abciximab
      was given in only < 9% of the cases. In another randomized, double-blind, placebo-controlled
      trial (ISAR-REACT-2) including ACS patients undergoing PCI, abciximab was administered in
      cath lab and was associated with a significant reduction of ischemic events in patients with
      NSTEMI, and did not lead to a measurable increase in major bleeding complications. However,
      it is not known whether abciximab is also superior to bivalirudin in patients with NSTEMI. We
      designed this study to assess whether abciximab added to unfractionated heparin is superior
      to bivalirudin in patients with NSTEMI.
    

Intervention name(s): Abciximab + UFH; Bivalirudin; Heparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute [maximum of 10 µg/minute] infusion for 12 hours); Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure); i.v. bolus of 70 units/kg/body weight of unfractionated heparin
Other intervention name(s): ReoPro; Angiox; unfractionated heparin
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin; Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSTEMI