Status:
COMPLETED
Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Shock, Cardiogenic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 treat...
Detailed Description
Routine upfront abciximab versus standard peri-procedural therapy in patients undergoing percutaneous coronary intervention for cardiogenic shock PRAGUE-7 Trial. Hypothesis: GP IIb/IIIa inhibitors i...
Eligibility Criteria
Inclusion
- Acute myocardial infarction (ST elevation, ST depression or bundle branch block on ECG) with indication to urgent coronary angiography
- 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
- Informed consent signed either by patient or his/her relative in case of diminished consciousness.
Exclusion
- 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)
- Cardiogenic shock caused by severe mitral regurgitation, rupture of free left ventricle wall or interventricular septum.
- Pre-randomization heparin dose \> 10 000 U during last 6 hours.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00420030
Start Date
September 1 2006
End Date
June 1 2009
Last Update
June 23 2009
Active Locations (1)
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1
Cardiocenter, University Hospital Vinohrady
Prague, Czechia, 100 34