Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: May 28, 2009
Last updated: June 24, 2015
Last verified: June 2015
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose [ Time Frame: 5 minutes post-dose ]

Secondary Outcome Measures:
  • Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose [ Time Frame: 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 [ Time Frame: 5 and 20 minutes post-dose ]
  • Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration ]

Enrollment: 270
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00910065

  Hide Study 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
Beijing, China, 100029
Beijing, China, 100037
Shanghai, China, 200080
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
San Juan, Alicante, Spain, 03550
Sabadell, Barcelona, Spain, 08208
Alicante, Spain, 03010
Valencia, Spain, 46015
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00910065     History of Changes
Other Study ID Numbers: 12946
2007-005163-94 ( EudraCT Number )
Study First Received: May 28, 2009
Last Updated: June 24, 2015

Keywords provided by Bayer:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetylsalicylic acid lysinate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on May 25, 2017