NCT00712101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,912

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 20, 2011

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

July 3, 2008

Last Update Submit

April 19, 2011

Conditions

ST-elevation Myocardial Infarction

Keywords

infarctioninterventionstentabciximabplatelets

Outcome Measures

Primary Outcomes (1)

  • Combined clinical endpoint: death, reinfarction, new congestive heart failure

    90 days

Secondary Outcomes (1)

  • ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints

    90 days

Study Arms (2)

1

EXPERIMENTAL

Abciximab bolus administration intracoronary

Drug: abciximab intracoronary

2

ACTIVE COMPARATOR

Abciximab bolus intravenously

Drug: abciximab intravenously

Interventions

abciximab intracoronaryDRUG

administer abciximab bolus intracoronary during primary percutaneous coronary intervention

1
abciximab intravenouslyDRUG

administer abciximab bolus intravenously during primary percutaneous coronary intervention

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical symptoms:
  • Angina pectoris \< 12 hours and
  • Persistent angina \> 30 minutes
  • 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
  • Informed consent

You may not qualify if:

  • No informed consent
  • Pregnancy
  • Known allergy to abciximab, ASA or heparin
  • Active peptic ulcus ventriculi or duodeni
  • Active, non-superficial bleeding
  • History of major surgery (including intracranial or intraspinal) \<4 weeks
  • active internal bleeding
  • Cerebrovascular complications \< 2 years
  • Known coagulation defect or thrombocytopenia
  • Arteriovenous malformations or aneurysm
  • Severe liver insufficiency, renal insufficiency requiring dialysis
  • Uncontrolled hypertension, hypertensive retinopathy
  • Vaskulitis
  • Thrombolysis \< 12 h
  • Participation in another trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Herz- und Gefäß-KLinik Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Herz und Diabeteszentrum Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Klinikum Links der Weser - Bremen

Bremen, 28277, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Carl-von-Basedow-Klinikum Merseburg

Merseburg, 06217, Germany

Location

Klinikum Pirna

Pirna, 01796, Germany

Location

Krankenhaus der Barmherzigen Brüder

Regensburg, 93049, Germany

Location

Jochen Wöhrle

Ulm, 89081, Germany

Location

Klinikum der Stadt Villingen-Schwenningen

Villingen-Schwenningen, 78045, Germany

Location

Related Publications (27)

  • 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.

    PMID: 18559698BACKGROUND

  • Lange T, Backhaus SJ, Schulz A, Evertz R, Kowallick JT, Bigalke B, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Cardiovascular magnetic resonance-derived left atrioventricular coupling index and major adverse cardiac events in patients following acute myocardial infarction. J Cardiovasc Magn Reson. 2023 Apr 13;25(1):24. doi: 10.1186/s12968-023-00929-w.

    PMID: 37046343DERIVED

  • Backhaus SJ, Rosel SF, Stiermaier T, Schmidt-Rimpler J, Evertz R, Schulz A, Lange T, Kowallick JT, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I, Schuster A. Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction. Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.

    PMID: 36268539DERIVED

  • Backhaus SJ, Aldehayat H, Kowallick JT, Evertz R, Lange T, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Artificial intelligence fully automated myocardial strain quantification for risk stratification following acute myocardial infarction. Sci Rep. 2022 Jul 18;12(1):12220. doi: 10.1038/s41598-022-16228-w.

    PMID: 35851282DERIVED

  • Jensch PJ, Stiermaier T, Reinstadler SJ, Feistritzer HJ, Desch S, Fuernau G, de Waha-Thiele S, Thiele H, Eitel I. Prognostic relevance of peri-infarct zone measured by cardiovascular magnetic resonance in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2022 Jan 15;347:83-88. doi: 10.1016/j.ijcard.2021.11.017. Epub 2021 Nov 10.

    PMID: 34767896DERIVED

  • Lange T, Stiermaier T, Backhaus SJ, Boom PC, Kowallick JT, de Waha-Thiele S, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Desch S, Hasenfuss G, Thiele H, Eitel I, Schuster A. Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction. Clin Res Cardiol. 2021 Feb;110(2):270-280. doi: 10.1007/s00392-020-01747-1. Epub 2020 Oct 20.

    PMID: 33083869DERIVED

  • Schuster A, Lange T, Backhaus SJ, Strohmeyer C, Boom PC, Matz J, Kowallick JT, Lotz J, Steinmetz M, Kutty S, Bigalke B, Gutberlet M, de Waha-Thiele S, Desch S, Hasenfuss G, Thiele H, Stiermaier T, Eitel I. Fully Automated Cardiac Assessment for Diagnostic and Prognostic Stratification Following Myocardial Infarction. J Am Heart Assoc. 2020 Sep 15;9(18):e016612. doi: 10.1161/JAHA.120.016612. Epub 2020 Sep 2.

    PMID: 32873121DERIVED

  • Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Navarra JL, Koschalka A, Evertz R, Lotz J, Kutty S, Hasenfuss G, Gutberlet M, Thiele H, Eitel I, Schuster A. Cardiac Magnetic Resonance Myocardial Feature Tracking for Optimized Risk Assessment After Acute Myocardial Infarction in Patients With Type 2 Diabetes. Diabetes. 2020 Jul;69(7):1540-1548. doi: 10.2337/db20-0001. Epub 2020 Apr 24.

    PMID: 32335515DERIVED

  • Schuster A, Backhaus SJ, Stiermaier T, Kowallick JT, Stulle A, Koschalka A, Lotz J, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I. Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1262-1270. doi: 10.1093/ehjci/jez077.

    PMID: 31329854DERIVED

  • Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Koschalka A, Navarra JL, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Hasenfuss G, Thiele H, Schuster A, Eitel I. Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction. Clin Res Cardiol. 2020 Mar;109(3):339-349. doi: 10.1007/s00392-019-01514-x. Epub 2019 Jul 5.

    PMID: 31278521DERIVED

  • Reinstadler SJ, Stiermaier T, Eitel C, Fuernau G, Saad M, Poss J, de Waha S, Mende M, Desch S, Metzler B, Thiele H, Eitel I. Impact of Atrial Fibrillation During ST-Segment-Elevation Myocardial Infarction on Infarct Characteristics and Prognosis. Circ Cardiovasc Imaging. 2018 Feb;11(2):e006955. doi: 10.1161/CIRCIMAGING.117.006955.

    PMID: 29391346DERIVED

  • Stiermaier T, Jobs A, de Waha S, Fuernau G, Poss J, Desch S, Thiele H, Eitel I. Optimized Prognosis Assessment in ST-Segment-Elevation Myocardial Infarction Using a Cardiac Magnetic Resonance Imaging Risk Score. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006774. doi: 10.1161/CIRCIMAGING.117.006774.

    PMID: 29122844DERIVED

  • Reinstadler SJ, Stiermaier T, Eitel C, Metzler B, de Waha S, Fuernau G, Desch S, Thiele H, Eitel I. Relationship between diabetes and ischaemic injury among patients with revascularized ST-elevation myocardial infarction. Diabetes Obes Metab. 2017 Dec;19(12):1706-1713. doi: 10.1111/dom.13002. Epub 2017 Jul 25.

    PMID: 28474817DERIVED

  • Reinstadler SJ, Stiermaier T, Eitel C, Saad M, Metzler B, de Waha S, Fuernau G, Desch S, Thiele H, Eitel I. Antecedent hypertension and myocardial injury in patients with reperfused ST-elevation myocardial infarction. J Cardiovasc Magn Reson. 2016 Nov 11;18(1):80. doi: 10.1186/s12968-016-0299-1.

    PMID: 27832796DERIVED

  • de Waha S, Eitel I, Desch S, Fuernau G, Poss J, Schuler G, Thiele H. Impact of multivessel coronary artery disease on reperfusion success in patients with ST-elevation myocardial infarction: A substudy of the AIDA STEMI trial. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):592-600. doi: 10.1177/2048872615624240. Epub 2015 Dec 21.

    PMID: 26691729DERIVED

  • Poss J, Desch S, Eitel C, de Waha S, Thiele H, Eitel I. Left Ventricular Thrombus Formation After ST-Segment-Elevation Myocardial Infarction: Insights From a Cardiac Magnetic Resonance Multicenter Study. Circ Cardiovasc Imaging. 2015 Oct;8(10):e003417. doi: 10.1161/CIRCIMAGING.115.003417.

    PMID: 26481162DERIVED

  • Jobs A, Eitel C, Poss J, Desch S, Thiele H, Eitel I. Effect of Pericardial Effusion Complicating ST-Elevation Myocardial Infarction as Predictor of Extensive Myocardial Damage and Prognosis. Am J Cardiol. 2015 Oct 1;116(7):1010-6. doi: 10.1016/j.amjcard.2015.07.007. Epub 2015 Jul 15.

    PMID: 26235929DERIVED

  • Eitel I, Poss J, Jobs A, Eitel C, de Waha S, Barkhausen J, Desch S, Thiele H. Left ventricular global function index assessed by cardiovascular magnetic resonance for the prediction of cardiovascular events in ST-elevation myocardial infarction. J Cardiovasc Magn Reson. 2015 Jul 16;17(1):62. doi: 10.1186/s12968-015-0161-x.

    PMID: 26174798DERIVED

  • Rommel KP, Badarnih H, Desch S, Gutberlet M, Schuler G, Thiele H, Eitel I. QRS complex distortion (Grade 3 ischaemia) as a predictor of myocardial damage assessed by cardiac magnetic resonance imaging and clinical prognosis in patients with ST-elevation myocardial infarction. Eur Heart J Cardiovasc Imaging. 2016 Feb;17(2):194-202. doi: 10.1093/ehjci/jev135. Epub 2015 Jun 9.

    PMID: 26060202DERIVED

  • Eitel I, de Waha S, Wohrle J, Fuernau G, Lurz P, Pauschinger M, Desch S, Schuler G, Thiele H. Comprehensive prognosis assessment by CMR imaging after ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2014 Sep 23;64(12):1217-26. doi: 10.1016/j.jacc.2014.06.1194.

    PMID: 25236513DERIVED

  • Rommel KP, Baum A, Mende M, Desch S, Gutberlet M, Schuler G, Thiele H, Eitel I. Prognostic significance and relationship of worst lead residual ST segment elevation with myocardial damage assessed by cardiovascular MRI in myocardial infarction. Heart. 2014 Aug;100(16):1257-63. doi: 10.1136/heartjnl-2013-305462. Epub 2014 Jun 4.

    PMID: 25049315DERIVED

  • Fuernau G, Eitel I, Wohrle J, Kerber S, Lauer B, Pauschinger M, Schwab J, Birkemeyer R, Pfeiffer S, Mende M, Brosteanu O, Neuhaus P, Desch S, de Waha S, Gutberlet M, Schuler G, Thiele H. Impact of long-term statin pretreatment on myocardial damage in ST elevation myocardial infarction (from the AIDA STEMI CMR Substudy). Am J Cardiol. 2014 Aug 15;114(4):503-9. doi: 10.1016/j.amjcard.2014.05.026. Epub 2014 Jun 6.

    PMID: 24994545DERIVED

  • Eitel I, Gehmlich D, Amer O, Wohrle J, Kerber S, Lauer B, Pauschinger M, Schwab J, Birkemeyer R, Zimmermann R, Mende M, de Waha S, Desch S, Gutberlet M, Schuler G, Thiele H. Prognostic relevance of papillary muscle infarction in reperfused infarction as visualized by cardiovascular magnetic resonance. Circ Cardiovasc Imaging. 2013 Nov;6(6):890-8. doi: 10.1161/CIRCIMAGING.113.000411. Epub 2013 Aug 23.

    PMID: 23973868DERIVED

  • Eitel I, Wohrle J, Suenkel H, Meissner J, Kerber S, Lauer B, Pauschinger M, Birkemeyer R, Axthelm C, Zimmermann R, Neuhaus P, Brosteanu O, de Waha S, Desch S, Gutberlet M, Schuler G, Thiele H. Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the AIDA STEMI trial. J Am Coll Cardiol. 2013 Apr 2;61(13):1447-54. doi: 10.1016/j.jacc.2013.01.048. Epub 2013 Feb 27.

    PMID: 23466078DERIVED

  • Thiele H, Wohrle J, Hambrecht R, Rittger H, Birkemeyer R, Lauer B, Neuhaus P, Brosteanu O, Sick P, Wiemer M, Kerber S, Kleinertz K, Eitel I, Desch S, Schuler G. Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial. Lancet. 2012 Mar 10;379(9819):923-931. doi: 10.1016/S0140-6736(11)61872-2. Epub 2012 Feb 21.

    PMID: 22357109DERIVED

  • Desch S, Siegemund A, Scholz U, Adam N, Eitel I, de Waha S, Furnau G, Lurz P, Wetzel S, Schuler G, Thiele H. Platelet inhibition and GP IIb/IIIa receptor occupancy by intracoronary versus intravenous bolus administration of abciximab in patients with ST-elevation myocardial infarction. Clin Res Cardiol. 2012 Feb;101(2):117-24. doi: 10.1007/s00392-011-0372-6. Epub 2011 Oct 21.

    PMID: 22015616DERIVED

  • Thiele H, Wohrle J, Neuhaus P, Brosteanu O, Sick P, Prondzinsky R, Birkemeyer R, Wiemer M, Kerber S, Schuehlen H, Kleinertz K, Axthelm C, Zimmermann R, Rittger H, Braun-Dullaeus RC, Lauer B, Burckhardt W, Ferrari M, Bergmann MW, Hambrecht R, Schuler G; Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) Investigators. Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial. Am Heart J. 2010 Apr;159(4):547-54. doi: 10.1016/j.ahj.2009.12.038.

    PMID: 20362711DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionInfarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Holger Thiele, MD, PhD

    Heart Center Leipzig - University Hospital

    STUDY CHAIR

  • Gerhard Schuler, MD, PhD

    Heart Center Leipzig - University Hospital

    STUDY DIRECTOR

  • Jochen Woehrle, MD, PhD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 20, 2011

Record last verified: 2009-08

Locations

DE(11)