Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
Outcome of patients with myocardial infarction complicated with cardiogenic shock is very
poor. Although early mechanical revascularization has been demonstrated superior to
conservative medical treatment, mortality range remains about 45-60%. Some medical registries
have showed further therapeutic benefit by administration of glycoprotein (GP) IIb/IIIa
inhibitors during PCI in patients with cardiogenic shock. However, there is no randomized
study that supports this therapeutic strategy in these high risk patients.
Hypothesis:
GP IIb/IIIa inhibitors improve angiographic (TIMI-flow), echocardiographic (LV function) and
clinical (combined end-point) outcomes in patients with myocardial infarction complicated
with cardiogenic shock.
Study design:
Open "pseudorandomized" multicenter, phase IV clinical trial.
Anticipated findings:
The investigators anticipate to document better angiographic, echocardiographic and clinical
outcome after upfront abciximab administration in comparison to standard periprocedural
therapy in patients undergoing PCI for cardiogenic shock. This would be the first randomized
clinical trial that could support this therapeutic strategy.
Phase:
Phase 4
Details
Lead Sponsor:
Charles University, Czech Republic
Collaborator:
Eli Lilly and Company
Treatments:
Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments