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

Bayer0 sites270 target enrollmentMarch 2011

InterventionsD,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet

DrugsD,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet

Overview

Phase: Phase 3
Intervention: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
Conditions: Acute Coronary Syndrome
Sponsor: Bayer
Enrollment: 270
Primary Endpoint: Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Arm 1

Intervention: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV

Arm 2

Intervention: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV

Arm 3

Intervention: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet

Outcomes

Primary Outcomes

Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose

Time Frame: 5 minutes post-dose

Secondary Outcomes

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)