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OpenTrials
Completed

NCT Number: NCT00299377

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abciximab i.v.

Drug

Abciximab i.c.

Drug

Primary outcomes

  1. Infarct size and microvascular obstruction assessed by MRI

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Mar 6, 2006
Registry last updated
Jul 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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