EUCTR2005-006029-94-BE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Eisai Limited
- Enrollment
- 720
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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