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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose	5 minutes post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Aspirin; Acute Coronary Syndrome; ACS
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Acetylsalicylic acid lysinate
• Other Study ID Numbers: 12946; 2007-005163-94 (EudraCT Number)