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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
Sponsor:
Information provided by:
University of Leipzig

Tracking Information
First Submitted Date  ICMJE July 3, 2008
First Posted Date  ICMJE July 9, 2008
Last Update Posted Date April 20, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Combined clinical endpoint: death, reinfarction, new congestive heart failure [ Time Frame: 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ST-elevation Myocardial Infarction
Intervention  ICMJE
  • Drug: abciximab intracoronary
    administer abciximab bolus intracoronary during primary percutaneous coronary intervention
  • Drug: abciximab intravenously
    administer abciximab bolus intravenously during primary percutaneous coronary intervention
Study Arms  ICMJE
  • Experimental: 1
    Abciximab bolus administration intracoronary
    Intervention: Drug: abciximab intracoronary
  • Active Comparator: 2
    Abciximab bolus intravenously
    Intervention: Drug: abciximab intravenously
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 6, 2009)
1912
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2008)
1868
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00712101
Other Study ID Numbers  ICMJE Final version 1.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Holger Thiele, University of Leipzig - Heart Center
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Leipzig
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP