A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute MI and Rescue-PCI
Condition: Myocardial Infarction; Ischemia
MeSH terms: Myocardial Infarction; Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Abciximab administration is safe and reduces ischemic complications in patients
           undergoing rescue PCI after failed thrombolysis compared to placebo.

        -  Abciximab improves angiographic scores and ventricular function after rescue-PCI
           compared to placebo.

        -  Intracoronary abciximab administration is more effective than intravenous route of
           administration in terms of acute and mid-term angiographic and clinical results.

        -  Intracoronary and intravenous bolus administration of abciximab dose provides similar
           platelet aggregation inhibition (PAI).

        -  There is a significant relationship between PAI after abciximab administration and
           indexes of myocardial perfusion.

        -  Routine use of Sirolimus-eluting stents (Cypher, Cordis, US) in rescue-PCI is associated
           with a low rate of target vessel revascularization.

        -  Cardiac MRI early and late after rescue-PCI provides detailed information on myocardial
           injury and irreversible necrosis, which are correlated with angiographic perfusion
           scores.

        -  After uncomplicated trans-radial rescue PCI, patients can be retransferred early to
           their referring center.
    

Detailed description: 
      OBJECTIVES AND END-POINTS

      The objectives of the present pilot study are to assess 1) the benefits and safety of
      abciximab i.c. or i.v. compared to placebo in rescue PCI and trans-radial approach, 2) the
      relationship between platelet aggregation inhibition and perfusion scores and to demonstrate
      3) better perfusion scores with i.c. abciximab as compared to i.v. abciximab or placebo.

      The Primary ANGIOGRAPHIC end-point will be the TIMI score and myocardial blush grade after
      rescue-PCI at baseline and at 6-months follow-up.

      The Secondary CLINICAL end-point will be:

        -  the composite of death, stroke, repeat-myocardial infarction, urgent target vessel
           revascularization and major bleedings at 30 days after rescue PCI.

        -  composite of death, repeat-myocardial infarction, repeat target vessel revascularization
           at 6 months following rescue PCI.

      The Secondary PLATELETS end-point will be the proportion of patients with platelet
      aggregation inhibition ≥ 95% and mean platelet aggregation inhibition 10 minutes post-bolus
      administration.

      The Secondary ANGIOGRAPHIC end-points will be the angiographic late loss and the restenosis
      rate (Diameter stenosis ≥ 50%) in the culprit artery.

      Other exploratory end-points include the feasibility and safety of early transfer to the
      referring hospital after uncomplicated primary PCI, cardiac MRI measurements and PAI 6 hr
      after bolus administration.
    

Intervention name(s): Abciximab
Intervention type(s): Drug
Intervention description(s): Abciximab (bolus) i.c. or i.v. or placebo, bolus dose is calculated according to current dosage (0.25 mg/kg) followed by 12 h infusion at 0.125 µg/kg/min (max 10µg/min).
Other intervention name(s): Abciximab (ReoPro)
Intervention MeSH terms: Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery stenting; Trans-radial; Intracoronary; Rescue-PCI