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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
D,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
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, ACS, Aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Concentration of Thromboxane B2 (TXB2) at 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
Serum Concentration of Prostacyclin Metabolite at 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
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

Full Information

First Posted
May 28, 2009
Last Updated
June 24, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00910065
Brief Title
BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, ACS, Aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Intervention Description
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
Primary Outcome Measure Information:
Title
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
Time Frame
5 minutes post-dose
Secondary Outcome Measure Information:
Title
Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
Time Frame
20 minutes post-dose
Title
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
Title
Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
Time Frame
5 and 20 minutes post-dose
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pregnant or breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
City
Beijing
ZIP/Postal Code
100029
Country
China
City
Beijing
ZIP/Postal Code
100037
Country
China
City
Shanghai
ZIP/Postal Code
200080
Country
China
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Coburg
State/Province
Bayern
ZIP/Postal Code
96450
Country
Germany
City
Dachau
State/Province
Bayern
ZIP/Postal Code
85221
Country
Germany
City
Melsungen
State/Province
Hessen
ZIP/Postal Code
34212
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50968
Country
Germany
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
City
Soest
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59494
Country
Germany
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67063
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67550
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
City
Berlin
ZIP/Postal Code
12351
Country
Germany
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119881
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
San Juan
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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