Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock - Full Text View

Sponsor:	Charles University, Czech Republic
Collaborator:	Eli Lilly and Company
Information provided by:	Charles University, Czech Republic
ClinicalTrials.gov Identifier:	NCT00420030

Purpose

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.

Condition	Intervention	Phase
Shock, Cardiogenic	Drug: Abciximab	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Shock

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:

Combined end-point death/reinfarction/stroke/TIMI-flow <3/EF <30% on day 30. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Left ventricular EF assessed by echocardiography on the day 30 (in deceased pts. EF assumed to be 0%) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Rate of major bleeding complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Myocardial blush score after PCI [ Time Frame: immediately after PCI ] [ Designated as safety issue: No ]
TIMI-flow after PCI [ Time Frame: immediatelly after PCI ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	September 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420030

Locations

Czech Republic
Cardiocenter, University Hospital Vinohrady
Prague, Czech Republic, 100 34

Sponsors and Collaborators

Charles University, Czech Republic

Eli Lilly and Company

Investigators

Study Director:	Petr Widimsky, Prof,MD,PhD	Charles University
Principal Investigator:	Petr Tousek, MD,PhD	Charles University

More Information

No publications provided by Charles University, Czech Republic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Apr 28.

Responsible Party:	Petr Tousek, Charles University
ClinicalTrials.gov Identifier:	NCT00420030 History of Changes
Other Study ID Numbers:	Charles University, Prague, MSM 0021620817
Study First Received:	January 8, 2007
Last Updated:	June 22, 2009
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by Charles University, Czech Republic:

upfront abciximab
PCI
cardiogenic shock

Additional relevant MeSH terms:

Shock
Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on February 09, 2012