None listed
Conditions
Brief summary
E5555 is a small molecule that inhibits activation of 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 CAD and not a replacement for any currently established forms of treatment for CAD. This study will look at the safety and tolerability of E5555 in CAD patients for a period of 24 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be up to 31 weeks, to allow for a maximum 3 weeks screening period. The patient would be asked to attend clinic for a total of 11 visits over the course of the study, with visits being between 1 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, ECGs (up to 11 in total); blood tests (up to 11 in total) and regular intake of study medication (three tablets taken once a day with breakfast). 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 3 additional visits and several additional blood samples being taken for pharmacokinetic and pharmacodynamic purposes.
Interventions
E5555 will be administered orally (po), once daily from day 1 to day 168 (week 24). 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). 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)
Sponsors
Eisai Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
The study will include men and women, aged between 45 and 80 years, inclusive, who have confirmed coronary artery disease defined as post-acute coronary syndrome (ACS) (> 4weeks); or myocardial infarction (MI) (>4 weeks) or Post percutaneous coronary intervention (PCI) (> 4 weeks) or coronary artery bypass surgery (CABG) (>12 weeks); or angina pectoris with documented (electrocardiogram or imaging study) ischemia; or angiographically documented lesion occluding =70% of a coronary vessel. Subjects must be at high risk as defined by meeting one or more of the following: Screening high-sensitivity c-reactive protein (hsCRP) = 3.0 mg/L, history of diabetes mellitus, under Rx treatment, documented history of peripheral arterial disease, documented history of thrombo-embolic transient ischemic attack (TIA) or stroke > 1 year prior to screening, documented history of carotid artery disease. All subjects must be receiving low dose aspirin (75-325 mg) and/or clopidogrel 75 mg once daily and/or ticlopidine 250 mg twice daily.
Exclusion criteria
Inability or unwillingness to provide fully informed consent to study participation; pregnancy; any history of a bleeding type condition or disorder; severe heart failure or heart rhythm problems; any cardiac surgery within the 12 weeks before admission or any cardiac event, such as heart attack or unstable angina, within the 30 days prior to admission; unstable diabetes requiring frequent alterations to prescribed anti-diabetic medication; any history of liver or kidney problems which causes significant abnormal blood results; the use of any medications shown to have potential adverse interactions with the study medication; recent significant infection or history of chronic infections requiring continuous antibiotic treatment; history of cancer unless adequate treated with no evdence of disease for at least 2 years and participation in any other clinical trial within the 30 days prior to admission.
Outcome results
None listed