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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV; Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV; Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	270 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	March 2011
Actual Primary Completion Date :	April 2014
Actual Study Completion Date :	July 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm 1	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.
Experimental: Arm 2	Drug: 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.
Active Comparator: Arm 3	Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet; Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

Outcome Measures

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Primary Outcome Measures :

1. Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose [ Time Frame: 5 minutes post-dose ]

Secondary Outcome Measures :

1. Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose [ Time Frame: 20 minutes post-dose ]
2. Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to Treatment [ Time Frame: 5 and 20 minutes post-dose ]
3. Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose [ Time Frame: 5 and 20 minutes post-dose ]
4. Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug Administration [ Time Frame: Post-randomization up to 30 days after single dose of study drug administration ]
5. 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 [ Time Frame: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Hide Study Locations

Locations

China, Guangdong
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510100
Guangzhou, Guangdong, China, 510120
Guangzhou, Guangdong, China, 510405
China, Hunan
Changsha, Hunan, China, 410013
China, Jiangxi
Nanchang, Jiangxi, China, 330006
China, Liaoning
Shenyang, Liaoning, China, 110004
Shenyang, Liaoning, China, 110016
China, Zhejiang
Hangzhou, Zhejiang, China, 310016
China
Beijing, China, 100029
Beijing, China, 100037
Shanghai, China, 200080
Germany
Bad Krozingen, Baden-Württemberg, Germany, 79189
Heidelberg, Baden-Württemberg, Germany, 69120
Coburg, Bayern, Germany, 96450
Dachau, Bayern, Germany, 85221
Melsungen, Hessen, Germany, 34212
Bonn, Nordrhein-Westfalen, Germany, 53105
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50968
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Soest, Nordrhein-Westfalen, Germany, 59494
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Mainz, Rheinland-Pfalz, Germany, 55131
Worms, Rheinland-Pfalz, Germany, 67550
Magdeburg, Sachsen-Anhalt, Germany, 39112
Berlin, Germany, 12351
Russian Federation
Moscow, Russian Federation, 109263
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 115516
Moscow, Russian Federation, 117292
Moscow, Russian Federation, 119881
Moscow, Russian Federation, 125101
Spain
San Juan, Alicante, Spain, 03550
Sabadell, Barcelona, Spain, 08208
Alicante, Spain, 03010
Valencia, Spain, 46015

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Additional Information:

Click here and search for drug information provided by the FDA. 

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Click here to find information about studies related to Bayer Healthcare products conducted in Europe. 

Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00910065 History of Changes
Other Study ID Numbers:	12946; 2007-005163-94 ( EudraCT Number )
First Posted:	May 29, 2009
Last Update Posted:	June 25, 2015
Last Verified:	June 2015

Keywords provided by Bayer:

Acute Coronary Syndrome; ACS; Aspirin

Additional relevant MeSH terms:

Syndrome; Acute Coronary Syndrome; Disease; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aspirin; Acetylsalicylic acid lysinate; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics	Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics