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Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI

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ClinicalTrials.gov Identifier: NCT00299377
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : July 3, 2008
Sponsor:
Information provided by:
University of Leipzig

Brief Summary:
Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Abciximab i.v. Drug: Abciximab i.c. Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction
Study Start Date : January 2006
Primary Completion Date : November 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab
U.S. FDA Resources




Primary Outcome Measures :
  1. Infarct size and microvascular obstruction assessed by MRI

Secondary Outcome Measures :
  1. ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Clinical symptoms:

    • Angina < 12 h persistent Angina > 30 min.
  2. ECG-Criteria:

    • ST-elevation > 1mm in ≥ 2 extremity leads
    • ST-elevation > 2mm in ≥ 2 contiguous anterior leads
  3. Informed consent

Exclusion Criteria:

  1. No consent
  2. Pregnancy
  3. Allergy against abciximab, ASA or heparin
  4. Active peptic ulcus ventriculi or duodeni
  5. Active non-superficial bleeding
  6. Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks
  7. Active internal bleeding
  8. Cerebrovascular complications < 2 years
  9. Known coagulation disorders, thrombocytopenia
  10. Arteriovenous malformations or aneurysms
  11. Severe Liver or renal dysfunction
  12. Severe untreated hypertension
  13. Active vasculitis
  14. Previous thrombolysis < 12 h

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 ClinicalTrials.gov identifier (NCT number): NCT00299377


Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele Heartcenter Leipzig GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00299377     History of Changes
Other Study ID Numbers: 1-Thiele
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: June 2008

Keywords provided by University of Leipzig:
STEMI
infarct size
primary PCI
no-reflow
ST-elevation myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs