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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Abciximab i.v.
Abciximab i.c.
Sponsored by
University of Leipzig
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring STEMI, infarct size, primary PCI, no-reflow, ST-elevation myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical symptoms: Angina < 12 h persistent Angina > 30 min. ECG-Criteria: ST-elevation > 1mm in ≥ 2 extremity leads ST-elevation > 2mm in ≥ 2 contiguous anterior leads Informed consent Exclusion Criteria: No consent Pregnancy Allergy against abciximab, ASA or heparin Active peptic ulcus ventriculi or duodeni Active non-superficial bleeding Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks Active internal bleeding Cerebrovascular complications < 2 years Known coagulation disorders, thrombocytopenia Arteriovenous malformations or aneurysms Severe Liver or renal dysfunction Severe untreated hypertension Active vasculitis Previous thrombolysis < 12 h

Sites / Locations

  • University of Leipzig - Heart Center

Outcomes

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)

Full Information

First Posted
March 2, 2006
Last Updated
July 2, 2008
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00299377
Brief Title
Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2007 (undefined)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
STEMI, infarct size, primary PCI, no-reflow, ST-elevation myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abciximab i.v.
Intervention Type
Drug
Intervention Name(s)
Abciximab i.c.
Primary Outcome Measure Information:
Title
Infarct size and microvascular obstruction assessed by MRI
Secondary Outcome Measure Information:
Title
ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical symptoms: Angina < 12 h persistent Angina > 30 min. ECG-Criteria: ST-elevation > 1mm in ≥ 2 extremity leads ST-elevation > 2mm in ≥ 2 contiguous anterior leads Informed consent Exclusion Criteria: No consent Pregnancy Allergy against abciximab, ASA or heparin Active peptic ulcus ventriculi or duodeni Active non-superficial bleeding Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks Active internal bleeding Cerebrovascular complications < 2 years Known coagulation disorders, thrombocytopenia Arteriovenous malformations or aneurysms Severe Liver or renal dysfunction Severe untreated hypertension Active vasculitis Previous thrombolysis < 12 h
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20675660
Citation
de Waha S, Desch S, Eitel I, Fuernau G, Zachrau J, Leuschner A, Gutberlet M, Schuler G, Thiele H. Impact of early vs. late microvascular obstruction assessed by magnetic resonance imaging on long-term outcome after ST-elevation myocardial infarction: a comparison with traditional prognostic markers. Eur Heart J. 2010 Nov;31(21):2660-8. doi: 10.1093/eurheartj/ehq247. Epub 2010 Jul 30.
Results Reference
derived
PubMed Identifier
18559698
Citation
Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
Results Reference
derived

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

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