Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock

NCT00420030 | Completed Phase 4 DMC

• 2 other identifiers: Charles University, PragueMSM 0021620817
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Shock, Cardiogenic

Keywords

upfront abciximab; PCI; cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30.

  30 days

Secondary Outcomes (4)

• Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%)

  30 days

• Rate of major bleeding complication

  30 days

• Myocardial blush score after PCI

  immediately after PCI

• TIMI-flow after PCI

  immediatelly after PCI

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1 - routine upfront administration of Reopro (Abciximab)

Drug: Abciximab

2

OTHER

Reopro (Abciximab) only if needed - according to physician

Drug: Abciximab

Interventions

Abciximab DRUG

Abciximab - IIb/IIIa GP inhibitor, dosage - bolus + continuous infusion

Also known as: Reopro

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Cardiocenter, University Hospital Vinohrady

Prague, 100 34, Czechia

Location

Related Publications (1)

• Tousek P, Rokyta R, Tesarova J, Pudil R, Belohlavek J, Stasek J, Rohac F, Widimsky P. Routine upfront abciximab versus standard periprocedural therapy in patients undergoing primary percutaneous coronary intervention for cardiogenic shock: The PRAGUE-7 Study. An open randomized multicentre study. Acute Card Care. 2011 Sep;13(3):116-22. doi: 10.3109/17482941.2011.567282. Epub 2011 Apr 28.

  PMID: 21526919 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Petr Widimsky, Prof,MD,PhD

  Charles University, Czech Republic

  STUDY DIRECTOR

• Petr Tousek, MD,PhD

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 9, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

CZ (1)