BAY81-8781, I.V. Aspirin in the Indication of Acute Coronary Syndrome (ACS) (ACUTE)
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00910065
First received: May 28, 2009
Last updated: June 24, 2015
Last verified: June 2015
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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: 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 |
| 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:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose [ Time Frame: 5 minutes post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose [ Time Frame: 20 minutes post-dose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose [ Time Frame: 5 and 20 minutes post-dose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 270 |
| Study Start Date: | March 2011 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00910065
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00910065
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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 |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00910065 History of Changes |
| Other Study ID Numbers: | 12946 2007-005163-94 |
| Study First Received: | May 28, 2009 |
| Last Updated: | June 24, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
Acute Coronary Syndrome ACS Aspirin |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016