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

Acute Coronary Syndrome Clinical Trial

— ACUTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910065
• Other study ID #: 12946
• Secondary ID: 2007-005163-94
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2009
• Last updated: June 24, 2015
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
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.
• D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
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.
• Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Germany,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose		5 minutes post-dose	No
Secondary	Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose		20 minutes post-dose	No
Secondary	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	No
Secondary	Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose		5 and 20 minutes post-dose	No
Secondary	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	Yes
Secondary	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	Yes

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