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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005163-94 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose | 5 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose | 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 | 5 and 20 minutes post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510080 | China | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV | Drug | 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. |
|
| Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet | Drug | Single oral dose of aspirin tablet at a dose of 300 mg on Day 1. |
|
| Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose | 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 | 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 | Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration |
| Guangzhou |
| Guangdong |
| 510100 |
| China |
| Guangzhou | Guangdong | 510120 | China |
| Guangzhou | Guangdong | 510405 | China |
| Changsha | Hunan | 410013 | China |
| Nanchang | Jiangxi | 330006 | China |
| Shenyang | Liaoning | 110004 | China |
| Shenyang | Liaoning | 110016 | China |
| Hangzhou | Zhejiang | 310016 | China |
| Beijing | 100029 | China |
| Beijing | 100037 | China |
| Shanghai | 200080 | China |
| Bad Krozingen | Baden-Wurttemberg | 79189 | Germany |
| Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Coburg | Bavaria | 96450 | Germany |
| Dachau | Bavaria | 85221 | Germany |
| Melsungen | Hesse | 34212 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Cologne | North Rhine-Westphalia | 50968 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Mönchengladbach | North Rhine-Westphalia | 41063 | Germany |
| Soest | North Rhine-Westphalia | 59494 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Worms | Rhineland-Palatinate | 67550 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Berlin | State of Berlin | 12351 | Germany |
| Moscow | 109263 | Russia |
| Moscow | 115093 | Russia |
| Moscow | 115516 | Russia |
| Moscow | 117292 | Russia |
| Moscow | 119881 | Russia |
| Moscow | 125101 | Russia |
| Alicante | Alicante | 03010 | Spain |
| San Juan | Alicante | 03550 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Valencia | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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