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

• Conditions: on-ST-segment Elevation Acute Coronary Syndrome; MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

• Registration Number: EUCTR2006-000296-15-BG
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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

•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 < 14 days prior to screening/baseline visit and/or requiring continuous antibiotic treatment
•Evidence of active pathological bleeding at screening/baseline or history of bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening/baseline visit, unless the cause has been definitely corrected
•History of intracranial bleeding e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy
•History of ischemic stroke or transient ischemic attack, within the past year prior to screening/baseline or known structural cerebral vascular lesion (eg, arteriovenous malformation [AVM], aneurysm)
•Haematological abnormalities: INR > 1.5 or PTT > 1.5 xULN, platelet count <100 x 103/ µL, haemoglobin < 10 g/dL at screening/baseline visit (day 1)
•History of NYHA class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening/baseline
•Patients with ST-segment changes at baseline attributed to left ventricular hypertrophy with repolarisation changes, bundle branch block and digoxin will be excluded.
•Percutaneous cardiac intervention or coronary artery surgery in the previous 12 weeks prior to the current hospital admission
•Significant (as determined by the investigator) cardiovascular events (such as a Q wave MI) within the past 30 days prior to the screening/baseline visit
•Planned elective surgical operation or major invasive procedures planned from 30 days prior to screening to completion of the study (the decision of what constitutes a major invasive procedure will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor)
•Unstable diabetes requiring frequent adjustments to medications (other than insulin) in the 30 days prior to the screening/baseline visit
•Documented history of chronic liver disease and/or screening/baseline ALT or AST > 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:
- Oral platelets 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)
- Oral anticoagulants (e.g. acecoumarol, warfarin)
- Fibrinolytics (eg, tPA, streptokinase, urokinase)
- NSAIDs (including COX-2 inhibitors) other than occasional use
- Potent CYP3A4 inhibitors
- Selected CYP 2D6 subtrates
- Herbals 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/baseline visit
•P

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified