AzTrials
AzTrials

Acute Coronary SyndromePhase 3ACUTENCT00910065

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

A Phase 3 study testing D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV, D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV and Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet in people with Acute Coronary Syndrome, run by Bayer at 37 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV, D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV and Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
37 sitesin 4 countries
Study dates
Mar 2011to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

37 sites in 4 countries.

37 sites in 4 countries

Germany15 sites

  • Study site

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Study site

    Berlin, State of Berlin, 12351

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Coburg, Bavaria, 96450

  • Study site

    Cologne, North Rhine-Westphalia, 50968

  • Study site

    Dachau, Bavaria, 85221

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Study site

    Magdeburg, Saxony-Anhalt, 39112

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Melsungen, Hesse, 34212

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Study site

    Soest, North Rhine-Westphalia, 59494

  • Study site

    Worms, Rhineland-Palatinate, 67550

Other trials in Germany

China12 sites

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100037

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou, Guangdong, 510100

  • Study site

    Guangzhou, Guangdong, 510120

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Hangzhou, Zhejiang, 310016

  • Study site

    Nanchang, Jiangxi, 330006

  • Study site

    Shanghai, 200080

  • Study site

    Shenyang, Liaoning, 110004

  • Study site

    Shenyang, Liaoning, 110016

Other trials in China

Russia6 sites

  • Study site

    Moscow, 109263

  • Study site

    Moscow, 115093

  • Study site

    Moscow, 115516

  • Study site

    Moscow, 117292

  • Study site

    Moscow, 119881

  • Study site

    Moscow, 125101

Other trials in Russia

Spain4 sites

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    San Juan, Alicante, 03550

  • Study site

    Valencia, Valencia, 46015

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
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
Keywords
Acute Coronary Syndrome, ACS, Aspirin
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IVDrug

    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 IVDrug

    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 TabletDrug

    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

Study groups in NCT00910065
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
Arm 2ExperimentalNot described
Receives: Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
Arm 3Active comparatorNot described
Receives: Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 minutes post-dose

Secondary outcomes (5)

  1. Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose

    Measured: 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

    Measured: 5 and 20 minutes post-dose

  3. Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose

    Measured: 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

    Measured: 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

    Measured: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2009 (estimated)
  2. Study startMar 2011
  3. Primary completionApr 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910065
Sponsor's protocol ID
12946
Other IDs
2007-005163-94
Acronym
ACUTE
Status last verified
Jun 2015
First submitted
28 May 2009
Last updated
25 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV, D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV and Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet in people with Acute Coronary Syndrome, run by Bayer at 37 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, China, Russia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose (time frame: 5 minutes post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in