Bay81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	270
Study Start Date:	March 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1	Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781) 300 mg Aspirin® N tablets p.o.
Experimental: Arm 2	Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781) 250 mg Aspirin i.v.
Experimental: Arm 3	Drug: Acetylsalicylic acid (Aspirin, BAY 81-8781) 500 mg Aspirin i.v.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910065

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For Trial Location Information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 37 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00910065 History of Changes
Other Study ID Numbers:	12946, 2007-005163-94
Study First Received:	May 28, 2009
Last Updated:	May 30, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Acute Coronary Syndrome
ACS
Aspirin

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013

Bay81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS) (ACUTE)