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

Sponsor

University of Leipzig (Other)

Overall Status

Completed

CT.gov ID

NCT00712101

Collaborator

(none)

1,912

Enrollment

Locations

Arms

Duration (Months)

173.8

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ST-elevation Myocardial Infarction	Drug: abciximab intracoronary Drug: abciximab intravenously	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1912 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Controlled Clinical Study to Compare Abciximab-bolus i.v. Versus i.c. in Primary PCI in Patients With Acute ST-elevation Myocardial Infarction

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Abciximab bolus administration intracoronary	Drug: abciximab intracoronary administer abciximab bolus intracoronary during primary percutaneous coronary intervention
Active Comparator: 2 Abciximab bolus intravenously	Drug: abciximab intravenously administer abciximab bolus intravenously during primary percutaneous coronary intervention

Arm

Intervention/Treatment

Experimental: 1

Abciximab bolus administration intracoronary

Drug: abciximab intracoronary

administer abciximab bolus intracoronary during primary percutaneous coronary intervention

Active Comparator: 2

Abciximab bolus intravenously

Drug: abciximab intravenously

administer abciximab bolus intravenously during primary percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

Combined clinical endpoint: death, reinfarction, new congestive heart failure [90 days]

Secondary Outcome Measures

ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical symptoms:

Angina pectoris < 12 hours and
Persistent angina > 30 minutes

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

Informed consent

Exclusion Criteria:

No informed consent
Pregnancy
Known allergy to abciximab, ASA or heparin
Active peptic ulcus ventriculi or duodeni
Active, non-superficial bleeding
History of major surgery (including intracranial or intraspinal) <4 weeks
active internal bleeding
Cerebrovascular complications < 2 years
Known coagulation defect or thrombocytopenia
Arteriovenous malformations or aneurysm
Severe liver insufficiency, renal insufficiency requiring dialysis
Uncontrolled hypertension, hypertensive retinopathy
Vaskulitis
Thrombolysis < 12 h
Participation in another trial

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Zentralklinik Bad Berka	Bad Berka	Germany	99437
2	Herz- und Gefäß-KLinik Bad Neustadt	Bad Neustadt	Germany	97616
3	Herz und Diabeteszentrum Bad Oeynhausen	Bad Oeynhausen	Germany	32545
4	Klinikum Links der Weser - Bremen	Bremen	Germany	28277
5	Klinikum Coburg	Coburg	Germany	96450
6	University of Leipzig - Heart Center	Leipzig	Germany	04289
7	Carl-von-Basedow-Klinikum Merseburg	Merseburg	Germany	06217
8	Klinikum Pirna	Pirna	Germany	01796
9	Krankenhaus der Barmherzigen Brüder	Regensburg	Germany	93049
10	Jochen Wöhrle	Ulm	Germany	89081
11	Klinikum der Stadt Villingen-Schwenningen	Villingen-Schwenningen	Germany	78045

Sponsors and Collaborators

University of Leipzig

Investigators

Study Chair: Holger Thiele, MD, PhD, Heart Center Leipzig - University Hospital
Study Director: Gerhard Schuler, MD, PhD, Heart Center Leipzig - University Hospital
Principal Investigator: Jochen Woehrle, MD, PhD, University of Ulm