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

April 19, 2011 updated by: University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1912

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka
      • Bad Neustadt, Germany, 97616
        • Herz- und Gefäß-KLinik Bad Neustadt
      • Bad Oeynhausen, Germany, 32545
        • Herz und Diabeteszentrum Bad Oeynhausen
      • Bremen, Germany, 28277
        • Klinikum Links der Weser - Bremen
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Leipzig, Germany, 04289
        • University of Leipzig - Heart Center
      • Merseburg, Germany, 06217
        • Carl-von-Basedow-Klinikum Merseburg
      • Pirna, Germany, 01796
        • Klinikum Pirna
      • Regensburg, Germany, 93049
        • Krankenhaus der Barmherzigen Brüder
      • Ulm, Germany, 89081
        • Jochen Wöhrle
      • Villingen-Schwenningen, Germany, 78045
        • Klinikum der Stadt Villingen-Schwenningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined clinical endpoint: death, reinfarction, new congestive heart failure
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2011

Last Update Submitted That Met QC Criteria

April 19, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Final version 1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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