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

Phase 3

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet; Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV; Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV

• Registration Number: NCT00910065
• Lead Sponsor: Bayer

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Study Start: 2011-03
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet	-
Arm 1	D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV	-
Arm 2	D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV	-

Primary Outcome Measures

Name	Time	Method
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose	5 minutes post-dose

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose	5 and 20 minutes post-dose
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
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