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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299377
• Other study ID #: 1-Thiele
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 2, 2006
• Last updated: July 2, 2008
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2008
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical symptoms:

• Angina < 12 h persistent Angina > 30 min.

2. ECG-Criteria:

• ST-elevation > 1mm in = 2 extremity leads

• ST-elevation > 2mm in = 2 contiguous anterior leads

3. Informed consent

Exclusion Criteria:

1. No consent

2. Pregnancy

3. Allergy against abciximab, ASA or heparin

4. Active peptic ulcus ventriculi or duodeni

5. Active non-superficial bleeding

6. Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks

7. Active internal bleeding

8. Cerebrovascular complications < 2 years

9. Known coagulation disorders, thrombocytopenia

10. Arteriovenous malformations or aneurysms

11. Severe Liver or renal dysfunction

12. Severe untreated hypertension

13. Active vasculitis

14. Previous thrombolysis < 12 h

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Abciximab i.v.

• Abciximab i.c.

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size and microvascular obstruction assessed by MRI
Secondary	ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)