drugset / Trial / NCT00420030

Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock

NCT00420030

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-09
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Abciximab Monoclonal antibody 0.125 ug/kg
Subject Abciximab Monoclonal antibody 0.25 ug/kg

Indications