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

July 2, 2008 updated by: University of Leipzig

Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Infarct size and microvascular obstruction assessed by MRI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Holger Thiele, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

July 3, 2008

Last Update Submitted That Met QC Criteria

July 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Thiele

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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