BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
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.
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