Trial Condition(s):

Acute Coronary Syndrome

BAY81-8781, I.V. Aspirin in the indication of Acute Coronary Syndrome (ACS) (ACUTE)

Bayer Identifier:

12946

ClinicalTrials.gov Identifier:

NCT00910065

EudraCT Number:

2007-005163-94

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
270
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Aspirin (Acetylsalicylic Acid, BAY81-8781)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Vivantes Klinikum Neukölln

Berlin, Germany, 12351

Status
Terminated
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Terminated
 
Locations

Hospital General Universitario de Alicante

Alicante, Spain, 03010

Status
Terminated
 
Locations

Hospital Arnau de Vilanova de Valencia

Valencia, Spain, 46015

Status
Terminated
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Terminated
 
Locations

City Clinical Hospital N 12

Moscow, Russia, 115516

Status
Terminated
 
Locations

Municipal Hospital N 4

Moscow, Russia, 115093

Status
Terminated
 
Locations

City Clinical Hospital n.a. Botkin

Moscow, Russia, 125101

Status
Terminated
 
Locations

Cardiovascular Institute and Fuwai Hospital, CAMS & PUMC

Beijing, China, 100037

Status
Terminated
 
Locations

Guangdong General Hospital

Guangzhou, China, 510100

Status
Terminated
 
Locations

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China, 510080

Status
Terminated
 
Locations

Guangdong Provincial Hospital of TCM

Guangzhou, China, 510120

Status
Terminated
 
Locations

General Hospital of Shenyang Military Area

Shenyang, China, 110016

Status
Terminated
 
Locations

Sir Run Run Shaw Hospital

Hangzhou, China, 310016

Status
Terminated
 
Locations

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
 
Locations

Marienkrankenhaus Soest

Soest, Germany, 59494

Status
Terminated
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39112

Status
Completed
 
Locations

Amper Kliniken AG - Klinikum Dachau

Dachau, Germany, 85221

Status
Completed
 
Locations

Hospital de San Juan

San Juan, Spain, 03550

Status
Terminated
 
Locations

Municipal Hospital N 68

Moscow, Russia, 109263

Status
Terminated
 
Locations

Municipal Hospital N 64

Moscow, Russia, 117292

Status
Terminated
 
Locations

1st Moscow State Medical University named after I.M.Sechenov

Moscow, Russia, 119881

Status
Terminated
 
Locations

China-Japan Friendship Hospital

Beijing, China, 100029

Status
Terminated
 
Locations

1st Affiliated Hosp., Guangzhou Univ. TCM

Guangzhou, China, 510405

Status
Terminated
 
Locations

Shengjing Hosp. of China Medical Univ.

Shenyang, China, 110004

Status
Terminated
 
Locations

The 2nd Affiliated Hospital of Nanchang University

Nanchang, China, 330006

Status
Terminated
 
Locations

Shanghai First People's Hospital

Shanghai, China, 200080

Status
Terminated
 
Locations

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Status
Terminated
 
Locations

St. Antonius Krankenhaus gGmbH

Köln, Germany, 50968

Status
Completed
 
Locations

Universitätsherzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany, 79189

Status
Completed
 
Locations

Klinikum Coburg gGmbH

Coburg, Germany, 96450

Status
Completed
 
Locations

Asklepios Klinikum Melsungen

Melsungen, Germany, 34212

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Stadtkrankenhaus Worms gGmbH

Worms, Germany, 67550

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 

Trial Design