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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00927615
Other study ID # 200807
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 24, 2009
Last updated September 7, 2010
Start date September 2008
Est. completion date April 2011

Study information

Verified date March 2010
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Description:

The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.

Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.

Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 534
Est. completion date April 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
abciximab
0.25 mg/kg body weight (intracoronary)
abciximab
0.25 mg/kg body weight (intravenous)

Locations

Country Name City State
Netherlands University Medical Centre Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of ST-segment resolution >70% 30 to 60 minutes post-PCI No
Secondary Bleeding complications in-hospital Yes
Secondary Thrombolysis In Myocardial Infarction (TIMI) flow post-PCI No
Secondary Myocardial Blush Grade (MBG) post-PCI No
Secondary Incidence of distal embolization post-PCI No
Secondary persistent residual ST-segment deviation 30 to 60 minutes post-PCI No
Secondary enzymatic infarct size in-hospital No
Secondary Major Adverse Cardiac Events (MACE) 30 days No
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