BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
NCT ID: NCT00910065
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2011-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
Single IV dose of aspirin at a dose of 500 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
Arm 2
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
Single IV dose of aspirin at a dose of 250 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
Arm 3
Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
Interventions
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D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
Single IV dose of aspirin at a dose of 500 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
Single IV dose of aspirin at a dose of 250 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.
Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Changsha, Hunan, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Shanghai, , China
Bad Krozingen, Baden-Wurttemberg, Germany
Heidelberg, Baden-Wurttemberg, Germany
Coburg, Bavaria, Germany
Dachau, Bavaria, Germany
Melsungen, Hesse, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Mönchengladbach, North Rhine-Westphalia, Germany
Soest, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Worms, Rhineland-Palatinate, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Alicante, Alicante, Spain
San Juan, Alicante, Spain
Sabadell, Barcelona, Spain
Valencia, Valencia, Spain
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2007-005163-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12946
Identifier Type: -
Identifier Source: org_study_id
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