Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction

NCT ID: NCT00712101

Last Updated: 2011-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1912 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-04-30

Brief Summary

The purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure.

Detailed Description

In patients with acute ST-elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) is the preferred reperfusion regimen, if performed by experienced operators in a timely manner. Nevertheless, myocardial damage is not immediately terminated after successful epicardial reperfusion by primary PCI. Current strategies are directed to improve myocardial tissue perfusion, which is impaired in approximately 50% of patients and which has prognostic impact. Adjunctive intravenous abciximab administration is an established therapy to improve coronary microcirculation and reduce major cardiac adverse events.5-10 In randomized clinical trials intravenous abciximab administration has been studied. Clinical trials have shown that earlier administration results in higher preinterventional TIMI-flow with subsequent improved perfusion post PCI. However, in a pooled analysis there was no effect on mortality. As door-to-balloon-times getting shorter in current trials, earlier abciximab administration requires treatment in the prehospital setting, which poses substantial logistic obstacles. Another option might be intracoronary abciximab bolus administration which results in very high local platelet inhibitor concentrations. This might be favorable in dissolution of thrombi and microemboli with subsequent improved myocardial microcirculation, reduction of no-reflow, and infarct size. Currently, there is only limited clinical experience on the efficacy of intracoronary abciximab administration mainly restricted to case reports, retrospective registries or small randomized trials. In a recently published randomized clinical trial, we were able to show that intracoronary versus intravenous abciximab bolus administration has beneficial effects on the occurrence of no-reflow and infarct size assessed by contrast-enhancement magnetic resonance imaging. This led to a trend towards improved clinical outcome. The composite major adverse cardiac event rate, defined as death, reinfarction, target vessel revascularization, and new congestive heart failure, at 30 day follow-up was 15.6% after intravenous and 5.2% after intracoronary abciximab administration (relative risk 3.00; 95% confidence intervals 0.94-10.80; p=0.06).

Currently, there is no adequately powered clinical trial to assess the effects of intracoronary bolus in comparison to standard intravenous abciximab administration. Due to its general availability and its ease of intracoronary administration this treatment has overwhelming potential in clinical practice, which is much easier to achieve than a logistically cumbersome prehospital or interhospital transfer administration.

In the era of evidence-based medicine, such a trial is of paramount importance to achieve a break-through in abciximab use and a reduction of the high associated morbidity and mortality of STEMI patients.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Abciximab bolus administration intracoronary

Group Type: EXPERIMENTAL

abciximab intracoronary

Intervention Type: DRUG

administer abciximab bolus intracoronary during primary percutaneous coronary intervention

2

Abciximab bolus intravenously

Group Type: ACTIVE_COMPARATOR

abciximab intravenously

Intervention Type: DRUG

administer abciximab bolus intravenously during primary percutaneous coronary intervention

Interventions

abciximab intracoronary

administer abciximab bolus intracoronary during primary percutaneous coronary intervention

Intervention Type: DRUG

abciximab intravenously

administer abciximab bolus intravenously during primary percutaneous coronary intervention

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Clinical symptoms:

• Angina pectoris < 12 hours and
• Persistent angina > 30 minutes

2. ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:

• ST-segment elevation > 1mm in ≥ 2 extremity leads and/or
• ST-segment elevation > 2mm in ≥ 2 adjacent precordial leads

3. Informed consent

Exclusion Criteria

1. No informed consent

2. Pregnancy

3. Known allergy to abciximab, ASA or heparin

4. Active peptic ulcus ventriculi or duodeni

5. Active, non-superficial bleeding

6. History of major surgery (including intracranial or intraspinal) <4 weeks

7. active internal bleeding

8. Cerebrovascular complications < 2 years

9. Known coagulation defect or thrombocytopenia

10. Arteriovenous malformations or aneurysm

11. Severe liver insufficiency, renal insufficiency requiring dialysis

12. Uncontrolled hypertension, hypertensive retinopathy

13. Vaskulitis

14. Thrombolysis < 12 h

15. Participation in another trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

University of Leipzig - Heart Center

Principal Investigators

Holger Thiele, MD, PhD

Role: STUDY_CHAIR

Heart Center Leipzig - University Hospital

Gerhard Schuler, MD, PhD

Role: STUDY_DIRECTOR

Heart Center Leipzig - University Hospital

Jochen Woehrle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

Zentralklinik Bad Berka

Bad Berka, , Germany

Herz- und Gefäß-KLinik Bad Neustadt

Bad Neustadt an der Saale, , Germany

Herz und Diabeteszentrum Bad Oeynhausen

Bad Oeynhausen, , Germany

Klinikum Links der Weser - Bremen

Bremen, , Germany

Klinikum Coburg

Coburg, , Germany

University of Leipzig - Heart Center

Leipzig, , Germany

Carl-von-Basedow-Klinikum Merseburg

Merseburg, , Germany

Klinikum Pirna

Pirna, , Germany

Krankenhaus der Barmherzigen Brüder

Regensburg, , Germany

Jochen Wöhrle

Ulm, , Germany

Klinikum der Stadt Villingen-Schwenningen

Villingen-Schwenningen, , Germany

Countries

Germany

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Other Identifiers

Final version 1.1

Identifier Type: -

Identifier Source: org_study_id