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

Phase 2

Completed

• Conditions: ACS; Acute Coronary Syndrome; 10011082

• Registration Number: NL-OMON34002
• Lead Sponsor: PRA Belgium BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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 and treatment possible within 72 hours of symptoms. Every effort should be made to randomize and treat eligible subjects as soon after hospital admission as possible.
* Age 18*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)

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: platelet count <100 x 103 /
*L, 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.
* A marked prolongation of QT/QTc interval (>500 ms) at the screening/baseline visit (Day 1)
* Percutaneous cardiac intervention or coronary artery surgery in the previous 12 weeks
prior to the screening/baseline visit
* 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 lowgrade
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:
o Oral 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)
o Anticoagulants (e.g. coumadin, warfarin)
o Fibrinolytics (eg, tPA, streptokinase, urokinase)
o NSAIDs, other than occasional use
o COX-2 inhibitors (other than occasional use)
o Potent and moderate CYP (global) 3A4

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>see study objectives</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>see study objectives</p><br>