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

NCT00910065 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2015-06-25

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

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

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.

DRUG

D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV

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.

DRUG

Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-04-30
Completion
2014-07-31

Countries

  • China
  • Germany
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00910065 on ClinicalTrials.gov