Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles University, Czech Republic
• Collaborator: Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

1. Acute myocardial infarction (ST elevation, ST depression or bundle branch block on ECG) with indication to urgent coronary angiography

2. Signs of cardiogenic shock including incompletely developed shock (at least one of the following must be present):

• Hypotension (BP < 90mmHg) and HR > 90/min

• Organ hypoperfusion-cold wett sweating skin and HR>90/min

• Need of catecholamine support to maintain BP> 90/min

• Klip II-III + systolic BP below 120 mmHg

3. Informed consent signed either by patient or his/her relative in case of diminished consciousness.

Exclusion Criteria:

1. Contraindications for the use of abciximab, either:

• Hypersensitiveness to Reopro components

• Active internal bleeding

• History of stroke in last 2 years

• Previous history (in last 2 month) of intracranial or intraspinal surgical intervention

• Atrio-venous malformation or aneurysm

• Known haemorrhagic diathesis or severe uncontrolled hypertension

• History of thrombocytopenia

• Therapy with oral anticoagulants (warfarin)

2. Cardiogenic shock caused by severe mitral regurgitation, rupture of free left ventricle wall or interventricular septum.

3. Pre-randomization heparin dose > 10 000 U during last 6 hours.