Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction

ST-elevation Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712101
• Other study ID #: Final version 1.1
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2008
• Last updated: April 19, 2011
• Start date: July 2008
• Est. completion date: April 2011

Study information

• Verified date: August 2009
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1912
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Drug:
• abciximab intracoronary
administer abciximab bolus intracoronary during primary percutaneous coronary intervention
• abciximab intravenously
administer abciximab bolus intravenously during primary percutaneous coronary intervention

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz- und Gefäß-KLinik Bad Neustadt	Bad Neustadt
Germany	Herz und Diabeteszentrum Bad Oeynhausen	Bad Oeynhausen
Germany	Klinikum Links der Weser - Bremen	Bremen
Germany	Klinikum Coburg	Coburg
Germany	University of Leipzig - Heart Center	Leipzig
Germany	Carl-von-Basedow-Klinikum Merseburg	Merseburg
Germany	Klinikum Pirna	Pirna
Germany	Krankenhaus der Barmherzigen Brüder	Regensburg
Germany	Jochen Wöhrle	Ulm
Germany	Klinikum der Stadt Villingen-Schwenningen	Villingen-Schwenningen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined clinical endpoint: death, reinfarction, new congestive heart failure		90 days	No
Secondary	ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints		90 days	No