BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS) (ACUTE)
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| ClinicalTrials.gov Identifier: NCT00910065 |
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Recruitment Status :
Completed
First Posted : May 29, 2009
Last Update Posted : June 25, 2015
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Coronary Syndrome | Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV Drug: D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 270 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2011 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | July 2014 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
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. |
| Experimental: Arm 2 |
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. |
| Active Comparator: Arm 3 |
Drug: Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
Single oral dose of aspirin tablet at a dose of 300 mg on Day 1. |
Primary Outcome Measures :
- Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose [ Time Frame: 5 minutes post-dose ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910065
Hide Study Locations
Locations
| China, Guangdong | |
| Guangzhou, Guangdong, China, 510080 | |
| Guangzhou, Guangdong, China, 510100 | |
| Guangzhou, Guangdong, China, 510120 | |
| Guangzhou, Guangdong, China, 510405 | |
| China, Hunan | |
| Changsha, Hunan, China, 410013 | |
| China, Jiangxi | |
| Nanchang, Jiangxi, China, 330006 | |
| China, Liaoning | |
| Shenyang, Liaoning, China, 110004 | |
| Shenyang, Liaoning, China, 110016 | |
| China, Zhejiang | |
| Hangzhou, Zhejiang, China, 310016 | |
| China | |
| Beijing, China, 100029 | |
| Beijing, China, 100037 | |
| Shanghai, China, 200080 | |
| Germany | |
| Bad Krozingen, Baden-Württemberg, Germany, 79189 | |
| Heidelberg, Baden-Württemberg, Germany, 69120 | |
| Coburg, Bayern, Germany, 96450 | |
| Dachau, Bayern, Germany, 85221 | |
| Melsungen, Hessen, Germany, 34212 | |
| Bonn, Nordrhein-Westfalen, Germany, 53105 | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Köln, Nordrhein-Westfalen, Germany, 50968 | |
| Mönchengladbach, Nordrhein-Westfalen, Germany, 41063 | |
| Soest, Nordrhein-Westfalen, Germany, 59494 | |
| Ludwigshafen, Rheinland-Pfalz, Germany, 67063 | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Worms, Rheinland-Pfalz, Germany, 67550 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Berlin, Germany, 12351 | |
| Russian Federation | |
| Moscow, Russian Federation, 109263 | |
| Moscow, Russian Federation, 115093 | |
| Moscow, Russian Federation, 115516 | |
| Moscow, Russian Federation, 117292 | |
| Moscow, Russian Federation, 119881 | |
| Moscow, Russian Federation, 125101 | |
| Spain | |
| San Juan, Alicante, Spain, 03550 | |
| Sabadell, Barcelona, Spain, 08208 | |
| Alicante, Spain, 03010 | |
| Valencia, Spain, 46015 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00910065 History of Changes |
| Other Study ID Numbers: |
12946 2007-005163-94 ( EudraCT Number ) |
| First Posted: | May 29, 2009 Key Record Dates |
| Last Update Posted: | June 25, 2015 |
| Last Verified: | June 2015 |
Keywords provided by Bayer:
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Acute Coronary Syndrome ACS Aspirin |
Additional relevant MeSH terms:
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Syndrome Acute Coronary Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Aspirin Acetylsalicylic acid lysinate Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |