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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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SRN007 (TRA2P-TIMI 50)
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A multi-centre, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of SCH 530348 in addition to standard of care in subjects with a history of atherosclerotic disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischaemic Events
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Topic
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Stroke (co-adopted by Diabetes, Cardiovascular)
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Portfolio Eligibility
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UKCRN adopted, commercial study
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Drug type
Therapy type
Cardiovascular
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Phase |
III
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Current Status
| Open |
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Sample Size
| 19500 |
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Lead Country
| England |
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Open to new sites
| No |
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Main Inclusion Criteria
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1. Subject may be of either sex and any race, and must be at least 18 years old
2. Subject must have evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems as follows:
a. Coronary Artery Disease as indicated by a history of presumed spontaneous Myocardial Infarction (MI) (hospitalised with final diagnosis of MI, excluding periprocedural or definite secondary MI [e.g. due to profound anaemia or hypertensive emergency, troponin increase in sepsis]) >/= 2 weeks but /= 2 weeks but
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Main Exclusion Criteria
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1. Clinically unstable at the time of enrolment
2. Any planned coronary revascularisation or peripheral intervention
3. Concurrent or anticipated treatment with anticoagulants such as warfarin (or derivatives, e.g. phenprocoumon), oral factor Xa inhibitors, or oral direct thrombin inhibitors
4. Concurrent or anticipated treatment with a potent inducer (e.g. rifampin) or potent inhibitor (e.g. ketoconazole, erthyromycin) of CYP3A4 isoenzymes
5. History of a bleeding tendency, or evidence of active abnormal bleeding within 30 days before enrolment
6. History at any time of intracranial haemorrhage, intracranial or spinal cord surgery, or a central nervous system tumour or aneurysm
7. Documented sustained severe hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg) at enrolment or within the previous 10 days
8. Severe valvular heart disease
9. History within 2 weeks prior to enrolment of major surgery other than mentioned above or of ischaemic (presumed thrombotic) stroke
10. Known platelet count <100,000/mm3 within 30 days before enrolment
11. Active hepatobiliary disease, or unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to two times or more the upper limit of the reference range (upper limit of “normal” [>/=2xULN])
12. Any serious illness or any condition that the investigator feels would a) pose a significant hazard to the subject if the investigational therapy were initiated, or b) would limit the prognosis of the subject, regardless of investigational therapy
13. Any serious medical comorbidity (e.g. active malignancy) such that the subject’s life expectancy is <24 months.
14. Previous participation in the current study
15. Current participation in any other study of investigational therapy, or participation in such a study within the last 30 days
16. Known hypersensitivity to any component of the current investigational product
17. Subject is a woman who is breast-feeding, pregnant, or who intends to become pregnant
18. Subject is part of the staff personnel directly involved with this study, or is a family member of the investigational staff.
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Chief Investigator(s)
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| Prof Robert Wilcox |
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Further details, please contact
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Ms Claire Falck
Worldwide Clinical Trials
Worldwide Clinical Trials
Isaac Newton Centre
Nottingham Science & Technology Park
Nottingham
Nottinghamshire
NG7 2RH
UNITED KINGDOM
Tel: 0115 956 7711
claire.falck@wwctrials.com
| Mr Naeem Khan
Worldwide Clinical Trials
Worldwide Clinical Trials
Isaac Newton Centre
Nottingham Science & Technology Park
Nottingham
Nottinghamshire
NG7 2RH
UNITED KINGDOM
naeem.khan@wwctrials.com
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Funder(s) |
INDUSTRY
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Sponsor(s) |
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