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 18, 2014
Last verified: June 2014
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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: 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:
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 ]
| Enrollment: | 270 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | April 2014 (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
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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, 510120 | |
| Guangzhou, Guangdong, China, 510100 | |
| Guangzhou, Guangdong, China, 510080 | |
| Guangzhou, Guangdong, China, 510405 | |
| China, Hunan | |
| Changsha, Hunan, China, 410013 | |
| China, Jiangxi | |
| Nanchang, Jiangxi, China, 330006 | |
| China, Liaoning | |
| Shenyang, Liaoning, China, 110016 | |
| Shenyang, Liaoning, China, 110004 | |
| China, Zhejiang | |
| Hangzhou, Zhejiang, China, 310016 | |
| China | |
| Beijing, China, 100037 | |
| Beijing, China, 100029 | |
| 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, 117292 | |
| Moscow, Russian Federation, 115516 | |
| Moscow, Russian Federation, 125101 | |
| Moscow, Russian Federation, 109263 | |
| Moscow, Russian Federation, 115093 | |
| Moscow, Russian Federation, 119881 | |
| 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:
No publications provided
| 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 18, 2014 |
| 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 Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Pain Signs and Symptoms Vascular Diseases Aspirin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics |
Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015