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Trial record 6 of 92 for:    ASPIRIN AND thromboxane

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00910065
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE May 28, 2009
First Posted Date  ICMJE May 29, 2009
Last Update Posted Date June 25, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose [ Time Frame: 5 minutes post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
The primary efficacy variable will be the TXB2 concentration at 5 minutes after study drug administration. [ Time Frame: Baseline and at 5 minutes after treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose [ Time Frame: 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 [ Time Frame: 5 and 20 minutes post-dose ]
  • Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose [ Time Frame: 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 [ Time Frame: Post-randomization up to 30 days 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 [ Time Frame: Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2009)
  • TXB2 values at 20 minutes [ Time Frame: At 20 minutes after treatment ]
  • Platelet aggregation inhibition [ Time Frame: Baseline and at 5 and 20 minutes after treatment ]
  • Serum prostacyclin levels [ Time Frame: Baseline and at 5 and 20 minutes after treatment ]
  • Incidence of post randomization deaths from all causes, cardiovascular deaths, myocardial re/infarctions and ischemic strokes [ Time Frame: 24 hours,7 days,30 days after treatment ]
  • Safety laboratory examinations, vital signs, physical examination, ECG, adverse events [ Time Frame: Day1 and Day 2 ]
  • Incidence of all post randomization strokes of unknown etiology [ Time Frame: 24 hours and 7 days after treatment ]
  • Incidence of all post randomization bleedings assessed according to the TIMI classification including hemorrhagic stroke [ Time Frame: 24 hours and 7 days after treatment ]
  • Hospital mortality during the hospitalization for ACS [ Time Frame: whole study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
  • Experimental: Arm 2
    Intervention: Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
  • Active Comparator: Arm 3
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2011)
270
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2009)
492
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Germany,   Russian Federation,   Spain
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT00910065
Other Study ID Numbers  ICMJE 12946
2007-005163-94 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP