A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201

• Conditions: Coronary Artery Disease; MedDRA version: 8.1Level: PTClassification code 10011078

• Registration Number: EUCTR2005-006029-94-BE
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Age 45 – 80 years, inclusive
• Males or Females (women of child-bearing potential must use adequate protection)
• Confirmed coronary artery disease defined as one of the following:
- Post-ACS or MI or Post PCI (greater than 4 weeks) or
- CABG (greater than 12 weeks) or
- Angina pectoris with documented (ECG or imaging study) ischemia or
- Angiographically documented lesion occluding =70% of a coronary vessel
And at high risk as defined by one or more of the following:
• Screening hsCRP = 3.0 mg/L
• History of diabetes mellitus under Rx treatment
• Documented history of peripheral arterial disease
• Documented history of Thrombo-embolic TIA or stroke greater than 1 year prior to screening
• Documented history of Carotid artery disease
All subjects must be receiving low-dose (75-325 mg) aspirin and or clopidogrel 75 mg once daily. Ticlopidine 250mg twice daily with or without low dose aspirin once daily is also allowed. These medications must be taken for at least 1 month prior to screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
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 in the past 30 days prior to Screening
• Evidence of active pathological bleeding at screening or history of bleeding (such as gastrointestinal or genitourinary) within the 6 months prior to Screening, unless the cause has been definitely corrected
• History of intracranial bleeding (eg, 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 or known structural cerebral vascular lesion (eg, arterial venous malformation, aneurysm)
• Hematological abnormalities: INR >1.5 or PTT >1.5 X ULN, Platelet count
<100 x (10)3/µL (<100 x (10)9/L), Hemoglobin <10 g/dL at Screening
• History of New York Heart Association class 3 or 4 congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at Screening
• Significant (as determined by the Investigator) cardiovascular events in the 30 days prior to the Screening Visit or newly prescribed or dose adjustments made to cardiovascular medications in the 30 days prior to the Screening Visit
• Planned elective surgical operation or major invasive procedure from 30 days before 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 Baseline Visit
• Documented history of chronic liver disease and/or Screening ALT or AST >3 x ULN or Total Bilirubin >1.5 x ULN (unless the abnormal bilirubin level is secondary to Gilbert’s syndrome)
• Documented presence of rheumatologic or autoimmune diseases requiring continuous treatment with anti-inflammatory agents
• Significant renal impairment, defined as creatinine clearance <30 mL/min
• History of cancer (other than basal cell carcinoma of the skin, cervical carcinoma in situ, or low-grade prostate cancer), unless adequately treated with no evidence of disease recurrence for at least 2 years
• Recent (within 14 days prior to Baseline Visit) significant infection or history of chronic infections with a recurrence <14 days prior to the Screening Visit and/or requiring continuous antibiotic treatment
• Use of any of the following drugs in the 30 days prior to Screening and for the duration of the study:
- Oral anti-thrombotics other than low dose aspirin (daily aspirin dose of 325 mg
or lower) and/or clopidogrel (75 mg) and/or ticlopidine (250 mg bid)
- Anticoagulants (eg, coumadin, warfarin)
- Fibrinolytics (eg, TPA, streptokinase, urokinase)
- NSAIDs, other than occasional use
- COX-2 inhibitors, other than occasional use
- Potent and moderate CYP (global) 3A4 inhibitors
- Selected CYP 2D6 substrates
- Herbals with antiplatelet properties: Gingko biloba, Horse chestnut
(Aesculus hippocastanum)
• Use of another investigational drug within 30 days prior to the Screening Visit or use of an investigational device (eg, unapproved stent) within 12 weeks prior to the Screening Visit
• Pregnant, or nursing women.
• use of illicit drugs or alcohol abuse 3 months prior to the screening or during the course of the study.
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Study & Design

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