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History of Changes for Study: NCT00712101
Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction (AIDA STEMI)
Latest version (submitted April 19, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 3, 2008 None (earliest Version on record)
2 October 16, 2008 Recruitment Status, Study Status, References, Contacts/Locations, Eligibility and Conditions
3 February 12, 2009 Study Status, Contacts/Locations and Study Description
4 August 6, 2009 Study Identification, Study Status and Study Design
5 June 24, 2010 Study Status
6 April 19, 2011 Recruitment Status, Study Status, Contacts/Locations, Conditions and Sponsor/Collaborators
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Study NCT00712101
Submitted Date:  June 24, 2010 (v5)
Open or close this module Study Identification
Unique Protocol ID: Final version 1.1
Brief Title: Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction (AIDA STEMI)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2009
Overall Status: Recruiting
Study Start: July 2008
Primary Completion: October 2010 [Anticipated]
Study Completion: July 2011 [Anticipated]
First Submitted: July 3, 2008
First Submitted that
Met QC Criteria:		 July 3, 2008
First Posted: July 9, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 24, 2010
Last Update Posted: June 25, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Leipzig
Responsible Party:
Collaborators: Lilly Germany GmbH
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: ST-Elevation Myocardial Infarction
Keywords: infarction
intervention
stent
abciximab
platelets
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1912 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Holger Thiele, MD, PhD
Telephone: +49 341 8651426
Email: thielh@medizin.uni-leipzig.de
Central Contact Backup: Petra Neuhaus, PhD
Telephone: + 49 341 9716255
Email: petra.neuhaus@kksl.uni-leipzig.de
Study Officials: Holger Thiele, MD, PhD
Study Chair
Heart Center Leipzig - University Hospital
Gerhard Schuler, MD, PhD
Study Director
Heart Center Leipzig - University Hospital
Jochen Woehrle, MD, PhD
Principal Investigator
University of Ulm
Locations: Germany
Zentralklinik Bad Berka
[Recruiting]
Bad Berka, Germany, 99437
Contact:Contact: Bernward Lauer, MD +49 3645851201 b.lauer.kar@zentralklinik-bad-berka.de
Contact:Principal Investigator: Bernward Lauer, MD
Herz- und Gefäß-KLinik Bad Neustadt
[Recruiting]
Bad Neustadt, Germany, 97616
Contact:Contact: Sebastian Kerber, MD +49 9771 662302 kerber@kardiologie-bad-neustadt.de
Contact:Principal Investigator: Sebastian Kerber, MD
Herz und Diabeteszentrum Bad Oeynhausen
[Recruiting]
Bad Oeynhausen, Germany, 32545
Contact:Contact: Marcus Wiemer, MD +49 5731 97 1248 mwiemer@hdz-nrw.de
Contact:Principal Investigator: Marcus Wiemer, MD
Klinikum Links der Weser - Bremen
[Recruiting]
Bremen, Germany, 28277
Contact:Contact: Rainer Hambrecht, MD 0049 4218791430 rainer.hambrecht@klinikum-bremen-ldw.de
Contact:Principal Investigator: Rainer Hambrecht, MD
Klinikum Coburg
[Recruiting]
Coburg, Germany, 96450
Contact:Contact: Harald Rittger, MD +49 9561 22-33215 harald.rittger@klinikum-coburg.de
Contact:Principal Investigator: Harald Rittger, MD
University of Leipzig - Heart Center
[Recruiting]
Leipzig, Germany, 04289
Contact:Contact: Holger Thiele, MD 0049 3418651426 thielh@medizin.uni-leipzig.de
Contact:Contact: Anja Leuschner 0049 3418651426 anja.leuschner@med.uni-leipzig.de
Contact:Principal Investigator: Holger Thiele, MD
Carl-von-Basedow-Klinikum Merseburg
[Recruiting]
Merseburg, Germany, 06217
Contact:Contact: Roland Prondzinsky, MD +49 3461 272001 r.prondzinsky@klinikum-merseburg.de
Contact:Principal Investigator: Roland Prondzinsky, MD
Klinikum Pirna
[Recruiting]
Pirna, Germany, 01796
Contact:Contact: Christoph Axthelm, MD +49 3501766 -1526 c.axthelm.kard@klinikum-pirna.de
Contact:Principal Investigator: Christoph Axthelm, MD
Krankenhaus der Barmherzigen Brüder
[Recruiting]
Regensburg, Germany, 93049
Contact:Contact: Peter Sick, MD +49 941 369 2100 peter.sick@barmherzige-regensburg.de
Contact:Principal Investigator: Peter Sick, MD
Jochen Wöhrle
[Recruiting]
Ulm, Germany, 89081
Contact:Contact: Jochen Wöhrle, MD 0049 731-500-45001 jochen.woehrle@uniklinik-ulm.de
Contact:Principal Investigator: Jochen Wöhrle, MD
Klinikum der Stadt Villingen-Schwenningen
[Recruiting]
Villingen-Schwenningen, Germany, 78045
Contact:Contact: Ralf Brikemeyer, MD +49 7721 933035 ralf.birkemeyer@sbk-vs.de
Contact:Principal Investigator: Ralf Birkemeyer, MD
Open or close this module IPDSharing
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Open or close this module References
Citations: Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16. PubMed 18559698
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