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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00910065
First received: May 28, 2009
Last updated: June 18, 2014
Last verified: June 2014

May 28, 2009
June 18, 2014
March 2011
April 2014   (final data collection date for primary outcome measure)
The primary efficacy variable will be the TXB2 (Thromboxane B2) concentration at 5 minutes after study drug administration. [ Time Frame: Baseline and at 5 minutes after treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00910065 on ClinicalTrials.gov Archive Site
  • TXB2 (Thromboxane B2) values at 20 minutes [ Time Frame: At 20 minutes after treatment ] [ Designated as safety issue: No ]
  • Platelet aggregation inhibition [ Time Frame: Baseline and at 5 and 20 minutes after treatment ] [ Designated as safety issue: No ]
  • Serum prostacyclin levels [ Time Frame: Baseline and at 5 and 20 minutes after treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety laboratory examinations, vital signs, physical examination, ECG, adverse events collection [ Time Frame: Day1 and Day 2 ] [ Designated as safety issue: Yes ]
  • Incidence of all post randomization strokes of unknown etiology [ Time Frame: 24 hours and 7 days after treatment ] [ Designated as safety issue: Yes ]
  • Incidence of all post randomization bleedings assessed according to the TIMI (thrombolysis in myocardial infarction) classification including hemorrhagic stroke [ Time Frame: 24 hours and 7 days after treatment ] [ Designated as safety issue: Yes ]
  • Hospital mortality during the hospitalization for ACS (Acute Coronary Syndrome) [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
  • TXB2 values at 20 minutes [ Time Frame: At 20 minutes after treatment ] [ Designated as safety issue: No ]
  • Platelet aggregation inhibition [ Time Frame: Baseline and at 5 and 20 minutes after treatment ] [ Designated as safety issue: No ]
  • Serum prostacyclin levels [ Time Frame: Baseline and at 5 and 20 minutes after treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety laboratory examinations, vital signs, physical examination, ECG, adverse events [ Time Frame: Day1 and Day 2 ] [ Designated as safety issue: Yes ]
  • Incidence of all post randomization strokes of unknown etiology [ Time Frame: 24 hours and 7 days after treatment ] [ Designated as safety issue: Yes ]
  • Incidence of all post randomization bleedings assessed according to the TIMI classification including hemorrhagic stroke [ Time Frame: 24 hours and 7 days after treatment ] [ Designated as safety issue: Yes ]
  • Hospital mortality during the hospitalization for ACS [ Time Frame: whole study period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS)
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
    300 mg Aspirin N tablets p.o.
  • Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
    250 mg Aspirin i.v.
  • Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
    500 mg Aspirin i.v.
  • Active Comparator: Arm 1
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
  • Experimental: Arm 2
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
  • Experimental: Arm 3
    Intervention: Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Spain,   Germany,   Russian Federation
 
NCT00910065
12946, 2007-005163-94
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

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