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

Bayer

Status and phase

Completed

Phase 3

Conditions

Acute Coronary Syndrome

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00910065

12946

2007-005163-94 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

270 patients

Sex

All

Ages

18+ years old

Volunteers

No 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