Status:
COMPLETED
Antithrombotic Triple Therapy in Humans
Lead Sponsor:
Medical University of Vienna
Conditions:
Atrial Fibrillation
Acute Coronary Syndrome
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief Summary
Background:The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic acid (ASA) with P2...
Eligibility Criteria
Inclusion
- Healthy male subjects; 18 - 40 years of age
- body mass index between 18 and 27 kg/m2
- Written informed consent
- Normal findings in medical \& bleeding history
- Non-smoking behaviour
Exclusion
- Regular intake of any medication including OTC drugs within 2 weeks before IMP administration
- Known coagulation disorders (e.g. haemophilia, von Willebrand´s disease)
- Known disorders with increased bleeding risk (e.g. peridontosis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer)
- Known sensitivity to common causes of bleeding (e.g. nasal)
- History of thromboembolism
- Impaired liver function (AST, ALT, GGT \>3 x ULN, Bilirubin \>2 x ULN)
- Impaired renal function (serum creatinine \> 1.3 mg/dl)
- Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis
- HIV-1/2-Ab, HbsAg or HCV-Ab positive serology
- Systolic blood pressure below 100 mmHg or above 145 mmHg, diastolic blood pressure above 95 mmHg
- Known allergy against test agents
- Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol
- Participation in another clinical trial during the preceding 3 weeks
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01812200
Start Date
October 1 2012
End Date
July 1 2013
Last Update
March 6 2014
Active Locations (1)
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1
Medical University of Vienna; Department of Clinical Pharmacology
Vienna, Austria, 1090