Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI - Full Text View

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00299377

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 II Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Abciximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

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:

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

Contacts and Locations

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

Publications indexed to this study:

Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-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. Epub 2008 Jun 16.

Study ID Numbers:	1-Thiele
Study First Received:	March 2, 2006
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00299377
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Leipzig:

STEMI
infarct size
primary PCI
no-reflow
ST-elevation myocardial infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Abciximab
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009