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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
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.
Unnamed facility
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
Time frame: 5 minutes post-dose
Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
Time frame: 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
Time frame: 5 and 20 minutes post-dose
Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
Time frame: 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
Time frame: 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
Time frame: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
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Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Changsha, Hunan, China
Unnamed facility
Nanchang, Jiangxi, China
Unnamed facility
Shenyang, Liaoning, China
Unnamed facility
Shenyang, Liaoning, China
Unnamed facility
Hangzhou, Zhejiang, China
Unnamed facility
Beijing, China
...and 27 more locations