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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Acetylsalicylic acid lysinate; Aspirin

Criteria

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