Status:
COMPLETED
BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
Lead Sponsor:
Bayer
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 AC...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00910065
Start Date
March 1 2011
End Date
July 1 2014
Last Update
June 25 2015
Active Locations (37)
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1
Guangzhou, Guangdong, China, 510080
2
Guangzhou, Guangdong, China, 510100
3
Guangzhou, Guangdong, China, 510120
4
Guangzhou, Guangdong, China, 510405