Trial Condition(s):
Acute Coronary Syndrome
BAY81-8781, I.V. Aspirin in the indication of Acute Coronary Syndrome (ACS) (ACUTE)
Bayer Identifier:
12946
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Vivantes Klinikum Neukölln Berlin, Germany, 12351 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Alicante Alicante, Spain, 03010 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Arnau de Vilanova de Valencia Valencia, Spain, 46015 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Hospital N 12 Moscow, Russia, 115516 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 4 Moscow, Russia, 115093 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Hospital n.a. Botkin Moscow, Russia, 125101 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cardiovascular Institute and Fuwai Hospital, CAMS & PUMC Beijing, China, 100037 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guangdong General Hospital Guangzhou, China, 510100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First Affiliated Hospital of Sun Yat-Sen University Guangzhou, China, 510080 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guangdong Provincial Hospital of TCM Guangzhou, China, 510120 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations General Hospital of Shenyang Military Area Shenyang, China, 110016 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Run Run Shaw Hospital Hangzhou, China, 310016 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marienkrankenhaus Soest Soest, Germany, 59494 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Otto-von-Guericke-Universität Magdeburg Magdeburg, Germany, 39112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Amper Kliniken AG - Klinikum Dachau Dachau, Germany, 85221 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de San Juan San Juan, Spain, 03550 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 68 Moscow, Russia, 109263 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 64 Moscow, Russia, 117292 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Moscow State Medical University named after I.M.Sechenov Moscow, Russia, 119881 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations China-Japan Friendship Hospital Beijing, China, 100029 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., Guangzhou Univ. TCM Guangzhou, China, 510405 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shengjing Hosp. of China Medical Univ. Shenyang, China, 110004 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 2nd Affiliated Hospital of Nanchang University Nanchang, China, 330006 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai First People's Hospital Shanghai, China, 200080 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Xiangya Hospital of Central South University Changsha, China, 410013 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Antonius Krankenhaus gGmbH Köln, Germany, 50968 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsherzzentrum Freiburg - Bad Krozingen Bad Krozingen, Germany, 79189 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Coburg gGmbH Coburg, Germany, 96450 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinikum Melsungen Melsungen, Germany, 34212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stadtkrankenhaus Worms gGmbH Worms, Germany, 67550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-doseTimeframe: 5 minutes post-dose
Secondary Outcome
- Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-doseTimeframe: 20 minutes post-dose
- Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to TreatmentTimeframe: 5 and 20 minutes post-dose
- Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-doseTimeframe: 5 and 20 minutes post-dose
- Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug AdministrationTimeframe: Post-randomization up to 30 days after single dose of study drug administration
- 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 AdministrationTimeframe: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
Additional Information
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