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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00712101
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : April 20, 2011
Information provided by:
University of Leipzig

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab

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

Primary Outcome Measures :
  1. Combined clinical endpoint: death, reinfarction, new congestive heart failure [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712101

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Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Herz- und Gefäß-KLinik Bad Neustadt
Bad Neustadt, Germany, 97616
Herz und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, Germany, 32545
Klinikum Links der Weser - Bremen
Bremen, Germany, 28277
Klinikum Coburg
Coburg, Germany, 96450
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Carl-von-Basedow-Klinikum Merseburg
Merseburg, Germany, 06217
Klinikum Pirna
Pirna, Germany, 01796
Krankenhaus der Barmherzigen Brüder
Regensburg, Germany, 93049
Jochen Wöhrle
Ulm, Germany, 89081
Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen, Germany, 78045
Sponsors and Collaborators
University of Leipzig
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00712101    
Other Study ID Numbers: Final version 1.1
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: August 2009
Keywords provided by University of Leipzig:
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors