Clinical trial NCT00910065: BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
ACS
Aspirin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
timeFrame: 5 minutes post-dose
Secondary outcomes:
measure: Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
timeFrame: 20 minutes post-dose
measure: Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to Treatment
timeFrame: 5 and 20 minutes post-dose
measure: Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
timeFrame: 5 and 20 minutes post-dose
measure: Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug Administration
timeFrame: Post-randomization up to 30 days after single dose of study drug administration
measure: 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
timeFrame: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Changsha
country: China
state: Hunan
city: Nanchang
country: China
state: Jiangxi
city: Shenyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Hangzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Bad Krozingen
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Coburg
country: Germany
state: Bayern
city: Dachau
country: Germany
state: Bayern
city: Melsungen
country: Germany
state: Hessen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Soest
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Worms
country: Germany
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Berlin
country: Germany
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: San Juan
country: Spain
state: Alicante
city: Sabadell
country: Spain
state: Barcelona
city: Alicante
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: