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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00299377
First received: March 2, 2006
Last updated: July 2, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Abciximab i.v.
Drug: Abciximab i.c.
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

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

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

Estimated Enrollment: 150
Study Start Date: January 2006
Study Completion Date: February 2008
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00299377

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

No publications provided by University of Leipzig

Additional 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
Study First Received: March 2, 2006
Last Updated: July 2, 2008
Health Authority: Germany: Ethics Commission

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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014