"A Randomised, Double-Blind, Placebo-Controlled study to determine the safety and tolerability of E5555 in patients admitted to hospital with symptoms of Acute Coronary Syndrome"
A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome
Eisai Ltd
600 participants
Dec 3, 2007
Interventional
Conditions
Summary
E5555 is a small molecule that inhibits activation of protease-activated receptor 1 (PAR-1), the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for Acute Coronary Syndrome (ACS) and not a replacement for any currently established forms of treatment for Acute Coronary Syndrome (ACS). This study will look at the safety and efficacy of E5555 in patients admitted to hospital with symptoms, and objective evidence, of acute coronary syndrome, for a period of 12 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be 16 weeks. The patients would be seen initially on a daily basis during the hospitalisaiton period, and once discharged, asked to attend clinic for a total of 5 visits over the outpatient phase of the study. Visits will be between 2 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, electrocardiongrams (up to 11 in total); blood draws (8 in total) and regular intake of study medication (three tables taken once a day with breakfast). Continuous electrocardiogram (ECG) monitoring (Holter monitoring) will also be done for the first 48 hours following randomisation. Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail additional blood samples being taken for pharmacokinetics (PK) and platelet aggregation purposes
Eligibility
Plain Language Summary
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Interventions
After a single, orally administered, loading dose of E5555 400 mg on day 1 (four 100 mg active tablets) or placebo 400 mg (four 100 mg placebo tablets), E5555 will be administered orally (po), once daily from day 2 to day 84 (week 12). E5555 50 mg (one 50 mg active and two 100 mg placebo tablets), E5555 100 mg (one 50 mg placebo, one 100 mg active and one 100 mg placebo tablet) and E5555 200 mg (one 50 mg placebo and two 100 mg active tablets). Control arm: Placebo (one 50 mg placebo and two 100 mg placebo tablets).
Locations(2)
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ACTRN12607000544471