BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)

Last updated: June 24, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Cardiac Disease

Coronary Artery Disease

Chest Pain

Treatment

N/A

Clinical Study ID

NCT00910065
12946
2007-005163-94
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to investigate whether intravenous administration (injected into a vein) of acetylsalicylic acid (Aspirin) in doses of 250 and 500 mg is superior to oral treatment of ACS with tablets containing 300 mg of Aspirin.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Angina pectoris lasting for more than 20 minutes within the last 24 hours before studydrug treatment (or equivalent acute symptoms such as increasing dyspnea, diaphoresis,nausea, abdominal/epigastric pain, syncope etc.)

  • ECG change suggestive for ischemia:

  • ST elevation or T-wave change or ST depression, new or presumed left bundle-branchblock (LBBB)

  • Elevated troponin T level > 0.01 ng/ml, levels according to local laboratory referencevalues

  • Risk factors for ACS such as known coronary artery disease (CAD), diabetes mellitus,impaired renal function, peripheral artery or cerebrovascular disease, currentsmoking.

Exclusion

Exclusion Criteria:

  • Treatment with acetylsalicylic acid (ASA) within 48 hours prior to study drugtreatment

  • Treatment with glycoprotein IIa/IIIb inhibitors within 48 hours prior to study drugtreatment and before the 20 minutes blood samples for thromboxane, prostacycline andplatelet aggregation measurement have been taken

  • Thrombolytic therapy within 24 hours before study drug treatment

  • Obligation for tracheal intubation and mechanical ventilation

  • Contraindications to ASA treatment

  • Known haemorrhagic diathesis

  • Evidence of an active gastrointestinal or urogenital bleeding

  • Stroke within 3 months prior to study drug treatment

  • Major surgery including coronary artery bypass graft (CABG) within 6 weeks prior tostudy drug treatment

  • Known severe hepatic or renal insufficiency

  • Pregnant or breast-feeding women

Study Design

Total Participants: 270
Study Start date:
March 01, 2011
Estimated Completion Date:
July 31, 2014

Study Description

In November 2009 it was the company's decision to cancel this study as an international trial. However, to support the local MA application of Aspirin i.v. for the indication "For the initial treatment in case of suspicion of acute coronary syndrome", Bayer decided to perform this trial in Germany as a domestic trial, with changed number of participants and study dates.

Connect with a study center

  • Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Changsha, Hunan 410013
    China

    Site Not Available

  • Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Shenyang, Liaoning 110016
    China

    Site Not Available

  • Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Beijing, 100029
    China

    Site Not Available

  • Shanghai, 200080
    China

    Site Not Available

  • Bad Krozingen, Baden-Württemberg 79189
    Germany

    Site Not Available

  • Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Coburg, Bayern 96450
    Germany

    Site Not Available

  • Dachau, Bayern 85221
    Germany

    Site Not Available

  • Melsungen, Hessen 34212
    Germany

    Site Not Available

  • Bonn, Nordrhein-Westfalen 53105
    Germany

    Site Not Available

  • Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • empty

    Köln, Nordrhein-Westfalen 50968
    Germany

    Site Not Available

  • Köln, Nordrhein-Westfalen 50968
    Germany

    Site Not Available

  • empty

    Mönchengladbach, Nordrhein-Westfalen 41063
    Germany

    Site Not Available

  • Mönchengladbach, Nordrhein-Westfalen 41063
    Germany

    Site Not Available

  • Soest, Nordrhein-Westfalen 59494
    Germany

    Site Not Available

  • Ludwigshafen, Rheinland-Pfalz 67063
    Germany

    Site Not Available

  • Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Worms, Rheinland-Pfalz 67550
    Germany

    Site Not Available

  • Magdeburg, Sachsen-Anhalt 39112
    Germany

    Site Not Available

  • Berlin, 12351
    Germany

    Site Not Available

  • Moscow, 119881
    Russian Federation

    Site Not Available

  • San Juan, Alicante 03550
    Spain

    Site Not Available

  • Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Alicante, 03010
    Spain

    Site Not Available

  • Valencia, 46015
    Spain

    Site Not Available

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