check_circleStudy Completed

Acute Coronary Syndrome

Bayer Identifier:

12946

ClinicalTrials.gov Identifier:

NCT00910065

EudraCT Number:

2007-005163-94

EU CT Number:

Not Available
BAY81-8781, I.V. Aspirin in the indication of Acute Coronary Syndrome (ACS)

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Angina pectoris lasting for more than 20 minutes within the last 24 hours before study drug 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-branch block (LBBB)
    - Elevated troponin T level > 0.01 ng/ml, levels according to local laboratory reference values
    - Risk factors for ACS such as known coronary artery disease (CAD), diabetes mellitus, impaired renal function, peripheral artery or cerebrovascular disease, current smoking.
  • - Treatment with acetylsalicylic acid (ASA) within 48 hours prior to study drug treatment
    - Treatment with glycoprotein IIa/IIIb inhibitors within 48 hours prior to study drug treatment and before the 20 minutes blood samples for thromboxane, prostacycline and platelet 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 to study drug treatment
    - Known severe hepatic or renal insufficiency
    - Pregnant or breast-feeding women

Trial summary

Enrollment Goal
270
Trial Dates
March 2011 - July 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Aspirin (Acetylsalicylic Acid, BAY81-8781)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Vivantes Klinikum NeuköllnBerlin, 12351, Germany
Terminated
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Terminated
Hospital General Universitario de AlicanteAlicante, 03010, Spain
Terminated
Hospital Arnau de Vilanova de ValenciaValencia, 46015, Spain
Terminated
Corporació Sanitària Parc TaulíSabadell, 08208, Spain
Terminated
City Clinical Hospital N 12Moscow, 115516, Russia
Terminated
Municipal Hospital N 4Moscow, 115093, Russia
Terminated
City Clinical Hospital n.a. BotkinMoscow, 125101, Russia
Terminated
Cardiovascular Institute and Fuwai Hospital, CAMS & PUMCBeijing, 100037, China
Terminated
Guangdong General HospitalGuangzhou, 510100, China
Terminated
The First Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, 510080, China
Terminated
Guangdong Provincial Hospital of TCMGuangzhou, 510120, China
Terminated
General Hospital of Shenyang Military AreaShenyang, 110016, China
Terminated
Sir Run Run Shaw HospitalHangzhou, 310016, China
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Terminated
Marienkrankenhaus SoestSoest, 59494, Germany
Completed
Universitätsklinikum EssenEssen, 45147, Germany
Completed
Otto-von-Guericke-Universität MagdeburgMagdeburg, 39112, Germany
Completed
Amper Kliniken AG - Klinikum DachauDachau, 85221, Germany
Terminated
Hospital de San JuanSan Juan, 03550, Spain
Terminated
Municipal Hospital N 68Moscow, 109263, Russia
Terminated
Municipal Hospital N 64Moscow, 117292, Russia
Terminated
1st Moscow State Medical University named after I.M.SechenovMoscow, 119881, Russia
Terminated
China-Japan Friendship HospitalBeijing, 100029, China
Terminated
1st Affiliated Hosp., Guangzhou Univ. TCMGuangzhou, 510405, China
Terminated
Shengjing Hosp. of China Medical Univ.Shenyang, 110004, China
Terminated
The 2nd Affiliated Hospital of Nanchang UniversityNanchang, 330006, China
Terminated
Shanghai First People's HospitalShanghai, 200080, China
Terminated
The Third Xiangya Hospital of Central South UniversityChangsha, 410013, China
Completed
St. Antonius Krankenhaus gGmbHKöln, 50968, Germany
Completed
Universitätsherzzentrum Freiburg - Bad KrozingenBad Krozingen, 79189, Germany
Completed
Klinikum Coburg gGmbHCoburg, 96450, Germany
Completed
Asklepios Klinikum MelsungenMelsungen, 34212, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Stadtkrankenhaus Worms gGmbHWorms, 67550, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany

Primary Outcome

  • Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
    date_rangeTime Frame:
    5 minutes post-dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
    date_rangeTime Frame:
    20 minutes post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to Treatment
    date_rangeTime Frame:
    5 and 20 minutes post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
    date_rangeTime Frame:
    5 and 20 minutes post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug Administration
    date_rangeTime Frame:
    Post-randomization up to 30 days after single dose of study drug administration
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of Post-randomization Deaths From all Causes, Cardiovascular Deaths, Myocardial Re/Infarctions and Ischemic Strokes Within 24 Hours, 7 Days And 30 Days After Single Dose of Study Drug Administration
    date_rangeTime Frame:
    Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A prospective, randomized, verum controlled, open label, parallel group multi-center phase III clinical trial to demonstrate the superiority of 500 or 250 mg Aspirin® i.v. (BAY 81-8781) treatment versus 300 mg Aspirin® N tablets p.o. (BAY e4465A) in patients with Acute Coronary Syndrome, measured by time dependent thromboxane inhibition
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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