Coronary Artery Disease MedDRA version: 9.1 Level: PT Classification code 10011078 Term: Coronary artery disease
Conditions
Interventions
Product Name: TRIC
Product Code: E5555
Pharmaceutical Form: Tablet
Current Sponsor code: E5555
Other descriptive name: TRIC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Eisai Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Men and women (women of child-bearing potential must use adequate contraception) •Presenting with features of non-ST segment elevation ACS (unstable angina or MI without persistent ST elevation). There must be new onset or a worsening pattern of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitroglycerin for relief of the pain) •Randomisation possible within 24 hours of the onset of the most recent symptomatic episode. •Age 45–80 years inclusive and at least one of the following two criteria on admission: - Troponin T or I = ULN or CKMB = ULN for the local institution - ECG changes compatible with ischemia (i.e. ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Unwilling or unable to provide informed consent •History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder •Recent trauma or major surgery (within the 30 days prior to screening/baseline) •Recent (within 14 days prior to screening/baseline) significant infection or history of chronic infections with a recurrence 1.5 or PTT > 1.5 xULN, platelet count 3 x ULN or total bilirubin > 1.5 x ULN (unless the abnormal bilirubin is secondary to Gilbert’s syndrome) •History of rheumatologic or autoimmune diseases •Significant renal impairment, defined as creatinine clearance of < 30mL/min •History of cancer (other than basal cell carcinoma, cervical carcinoma in situ, or low-grade prostate cancer), unless adequately treated with no evidence of disease recurrence for at least 2 years •Use of any of the following drugs in the 30 days prior to the screening / baseline visit and for the duration of the study: oOral anti-thrombotics other than aspirin (daily aspirin dose of 325 mg or lower) and/or clopidogrel (75 mg chronically; loading dose allowed) and/or Ticlopidine (250mg BID) oAnticoagulants (e.g. coumadin, warfarin) oFibrinolytics (eg, tPA, streptokinase, urokinase) oNSAIDs, other than occasional use oCOX-2 inhibitors (other than occasional use) oPotent CYP (global) 3A4 inhibitors oSelected CYP 2D6 subtrates oHerbals with anti-platelet properties: ?Gingko biloba ?Horse chestnut (Aesculus hippocastanum) •Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, eg, unapproved stents) prior to sceening/bas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of ACS. This will be assessed for a period of up to 16 weeks (112 days). ;Secondary Objective: •To determine the effect of E5555 on major adverse cardiac events (MACE, which includes cardiovascular death, acute myocardial infarction [MI], stroke, refractory ischemia) and platelet aggregation in selected sites up to Weeks 1, 4, 12, and 16 or early termination (Days 7, 28, 84, and 112) following ACS. •To assess the effect of E5555 on overall bleeding (major, minor, or minimal) outcome up to 1, 4, 12, and 16 weeks (7, 28, 84, and 112 days), of E5555 administration. •To determine the effect of E5555 on the incidence of transient ischemia during the first 48 hours of treatment, assessed by a significant ST-segment shift. •12-lead continuous ECG monitoring (Holter) will also be obtained for the initial 48 hours following randomisation to detect transient ST-segment shifts. •To provide data that can be used to help determine the safe and effective clinical dose/dose range. ;Primary end point(s): The primary outcome will be proportions of patients with CEC-adjudicated major bleeds. Cross-classification tables of CEC-adjudicated major bleeds versus treatment group will be created. Safety and tolerability will be determined by comparison of incidences of treatment-emergent SAEs, treatment-emergent AEs, treatment-emergent abnormal lab values and changes in ECGs in the safety population. Two main secondary endpoints will be used to assess efficacy issues between the treatment groups. The first will be the proportion of patients with CEC-adjudicated MACEs.The second efficacy endpoint will be the proportion of subjects with 24-h Holter-detected ischemia as defined by a ST-segment shift = 0.1 mV below/above the baseline, = 1 minute in duration, and separated from other episodes of ST segment shift by = | — |
Countries
Belgium, Bulgaria, Czech Republic, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Sweden, United Kingdom
Outcome results
None listed