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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndrome

Intervention: 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 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Beijing 100037, China

Beijing 100029, China

Shanghai 200080, China

Berlin 12351, Germany

Moscow 115093, Russian Federation

Moscow 125101, Russian Federation

Moscow 115516, Russian Federation

Moscow 117292, Russian Federation

Moscow 109263, Russian Federation

Moscow 119881, Russian Federation

Alicante 03010, Spain

Valencia 46015, Spain

San Juan, Alicante 03550, Spain

Bad Krozingen, Baden-W├╝rttemberg 79189, Germany

Heidelberg, Baden-W├╝rttemberg 69120, Germany

Sabadell, Barcelona 08208, Spain

Coburg, Bayern 96450, Germany

Dachau, Bayern 85221, Germany

Guangzhou, Guangdong 510080, China

Guangzhou, Guangdong 510100, China

Guangzhou, Guangdong 510120, China

Guangzhou, Guangdong 510405, China

Melsungen, Hessen 34212, Germany

Changsha, Hunan 410013, China

Nanchang, Jiangxi 330006, China

Shenyang, Liaoning 110004, China

Shenyang, Liaoning 110016, China

Bonn, Nordrhein-Westfalen 53105, Germany

Essen, Nordrhein-Westfalen 45147, Germany

K├Âln, Nordrhein-Westfalen 50968, Germany

M├Ânchengladbach, Nordrhein-Westfalen 41063, Germany

Soest, Nordrhein-Westfalen 59494, Germany

Ludwigshafen, Rheinland-Pfalz 67063, Germany

Mainz, Rheinland-Pfalz 55131, Germany

Worms, Rheinland-Pfalz 67550, Germany

Magdeburg, Sachsen-Anhalt 39112, Germany

Hangzhou, Zhejiang 310016, China

Additional Information

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

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

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

Starting date: March 2011
Last updated: June 24, 2015

Page last updated: August 23, 2015

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