NCT00927615

Brief Summary

The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 8, 2010

Status Verified

March 1, 2010

Enrollment Period

1.7 years

First QC Date

June 24, 2009

Last Update Submit

September 7, 2010

Conditions

ST-Elevation Myocardial Infarction

Keywords

myocardial infarctionglycoprotein IIb/IIIapercutaneous coronary interventionthrombus aspirationmyocardial perfusion

Outcome Measures

Primary Outcomes (1)

  • incidence of ST-segment resolution >70%

    30 to 60 minutes post-PCI

Secondary Outcomes (7)

  • Bleeding complications

    in-hospital

  • Thrombolysis In Myocardial Infarction (TIMI) flow

    post-PCI

  • Myocardial Blush Grade (MBG)

    post-PCI

  • Incidence of distal embolization

    post-PCI

  • persistent residual ST-segment deviation

    30 to 60 minutes post-PCI

  • +2 more secondary outcomes

Study Arms (2)

intracoronary abciximab

EXPERIMENTAL

intracoronary administration of abciximab (0.25 mg/kg body weight)

Drug: abciximab

intravenous abciximab

ACTIVE COMPARATOR

intravenous administration of abciximab (0.25 mg/kg body weight)

Drug: abciximab

Interventions

abciximabDRUG

0.25 mg/kg body weight (intracoronary)

Also known as: ReoPro
intracoronary abciximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of STEMI defined by
  • chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission
  • time from onset of symptoms of less than 12 hours
  • ECG with ST-segment deviation of more than 0.1 mV in 2 or more leads

You may not qualify if:

  • rescue PCI after thrombolytic therapy
  • need for emergency coronary artery bypass grafting
  • presence of cardiogenic shock
  • known existence of a life-threatening disease with a life expectancy of less than 6 months
  • inability to provide informed consent
  • contra-indications for the use of abciximab (active internal bleeding, history of stroke within 2 years, recent major surgery or intracranial or intraspinal trauma or surgery within 2 months, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive or diabetic retinopathy, severe liver or kidney failure, and hypersensitivity to murine proteins)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

  • Gu YL, Fokkema ML, Kampinga MA, de Smet BJ, Tan ES, van den Heuvel AF, Zijlstra F. Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration. Trials. 2009 Sep 28;10:90. doi: 10.1186/1745-6215-10-90.

    PMID: 19785725DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Felix Zijlstra, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

April 1, 2011

Last Updated

September 8, 2010

Record last verified: 2010-03

Locations

NL(1)