Abciximab in Patients Undergoing Percutaneous Coronary Intervention for Cardiogenic Shock

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00420030
First received: January 8, 2007
Last updated: June 22, 2009
Last verified: June 2009
  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 4

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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014