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Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420030
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : June 23, 2009
Eli Lilly and Company
Information provided by:
Charles University, Czech Republic

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 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.


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.

Condition or disease Intervention/treatment Phase
Shock, Cardiogenic Drug: Abciximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Routine Upfront Abciximab Versus Standard Peri-Procedural Therapy in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock PRAGUE-7 Trial.
Study Start Date : September 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Abciximab

Arm Intervention/treatment
Active Comparator: 1
Arm 1 - routine upfront administration of Reopro (Abciximab)
Drug: Abciximab
Abciximab - IIb/IIIa GP inhibitor, dosage - bolus + continuous infusion
Other Name: Reopro

Reopro (Abciximab) only if needed - according to physician
Drug: Abciximab
Abciximab - IIb/IIIa GP inhibitor, dosage - bolus + continuous infusion
Other Name: Reopro

Primary Outcome Measures :
  1. Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%) [ Time Frame: 30 days ]
  2. Rate of major bleeding complication [ Time Frame: 30 days ]
  3. Myocardial blush score after PCI [ Time Frame: immediately after PCI ]
  4. TIMI-flow after PCI [ Time Frame: immediatelly after PCI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420030

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Czech Republic
Cardiocenter, University Hospital Vinohrady
Prague, Czech Republic, 100 34
Sponsors and Collaborators
Charles University, Czech Republic
Eli Lilly and Company
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Study Director: Petr Widimsky, Prof,MD,PhD Charles University
Principal Investigator: Petr Tousek, MD,PhD Charles University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Petr Tousek, Charles University Identifier: NCT00420030    
Other Study ID Numbers: Charles University, Prague
MSM 0021620817
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009
Keywords provided by Charles University, Czech Republic:
upfront abciximab
cardiogenic shock
Additional relevant MeSH terms:
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Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors