BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
ACUTE
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
2 other identifiers
interventional
270
4 countries
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
Typical duration for phase_3
37 active sites
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
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 29, 2009
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 25, 2015
June 1, 2015
3.1 years
May 28, 2009
June 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
5 minutes post-dose
Secondary Outcomes (5)
Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
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 Treatment
5 and 20 minutes post-dose
Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
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 Administration
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 Administration
Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
ACTIVE COMPARATORInterventions
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.
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.
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (37)
Unknown Facility
Guangzhou, Guangdong, 510080, China
Unknown Facility
Guangzhou, Guangdong, 510100, China
Unknown Facility
Guangzhou, Guangdong, 510120, China
Unknown Facility
Guangzhou, Guangdong, 510405, China
Unknown Facility
Changsha, Hunan, 410013, China
Unknown Facility
Nanchang, Jiangxi, 330006, China
Unknown Facility
Shenyang, Liaoning, 110004, China
Unknown Facility
Shenyang, Liaoning, 110016, China
Unknown Facility
Hangzhou, Zhejiang, 310016, China
Unknown Facility
Beijing, 100029, China
Unknown Facility
Beijing, 100037, China
Unknown Facility
Shanghai, 200080, China
Unknown Facility
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
Unknown Facility
Heidelberg, Baden-Wurttemberg, 69120, Germany
Unknown Facility
Coburg, Bavaria, 96450, Germany
Unknown Facility
Dachau, Bavaria, 85221, Germany
Unknown Facility
Melsungen, Hesse, 34212, Germany
Unknown Facility
Bonn, North Rhine-Westphalia, 53105, Germany
Unknown Facility
Cologne, North Rhine-Westphalia, 50968, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45147, Germany
Unknown Facility
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Unknown Facility
Soest, North Rhine-Westphalia, 59494, Germany
Unknown Facility
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Unknown Facility
Worms, Rhineland-Palatinate, 67550, Germany
Unknown Facility
Magdeburg, Saxony-Anhalt, 39112, Germany
Unknown Facility
Berlin, State of Berlin, 12351, Germany
Unknown Facility
Moscow, 109263, Russia
Unknown Facility
Moscow, 115093, Russia
Unknown Facility
Moscow, 115516, Russia
Unknown Facility
Moscow, 117292, Russia
Unknown Facility
Moscow, 119881, Russia
Unknown Facility
Moscow, 125101, Russia
Unknown Facility
Alicante, Alicante, 03010, Spain
Unknown Facility
San Juan, Alicante, 03550, Spain
Unknown Facility
Sabadell, Barcelona, 08208, Spain
Unknown Facility
Valencia, Valencia, 46015, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
May 29, 2009
Study Start
March 1, 2011
Primary Completion
April 1, 2014
Study Completion
July 1, 2014
Last Updated
June 25, 2015
Record last verified: 2015-06