Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00712101
First received: July 3, 2008
Last updated: April 19, 2011
Last verified: August 2009
  Purpose

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 Intervention Phase
ST-elevation Myocardial Infarction
Drug: abciximab intracoronary
Drug: abciximab intravenously
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Combined clinical endpoint: death, reinfarction, new congestive heart failure [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1912
Study Start Date: July 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712101

Locations
Germany
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
Investigators
Study Chair: Holger Thiele, MD, PhD University of Leipzig
Study Director: Gerhard Schuler, MD, PhD University of Leipzig
Principal Investigator: Jochen Woehrle, MD, PhD University of Ulm
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00712101     History of Changes
Other Study ID Numbers: Final version 1.1
Study First Received: July 3, 2008
Last Updated: April 19, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University of Leipzig:
infarction
intervention
stent
abciximab
platelets

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014