NL-OMON34815
Completed
Phase 2
Maintenance of platelet inhiBition with cangreloR after dIscontinuation of thienopyriDines in patients undergoing surGEry: The BRIDGE trial - BRIDGE
Medicines Company0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- platelet inhibition
- Sponsor
- Medicines Company
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provide written informed consent before initiation of any study related procedures.
- •2\. Be at least 18 years of age.
- •3\. Anticipate non\-emergent coronary artery bypass graft (CABG) surgery, either \*onpump\* or \*off\-pump,\* no sooner than 48 hours from randomization but no longer than 7 days from randomization, with patient to remain hospitalized until planned CABG.
- •4\. Have received a thienopyridine (at least 75 mg of clopidogrel or 500 mg ticlopidine)
- •within 48 hours prior to enrollment in the study for the treatment of an acute coronary syndrome or as long\-term preventative therapy following drug\-eluting stent treatment.
Exclusion Criteria
- •1\. Confirmed of suspected pregnancy (if woman of child\-bearing potential) or lactating females
- •2\. Cerebrovascular accident within one year
- •3\. Intracranial neoplasm or history of intracranial surgery
- •4\. History of bleeding diathesis
- •5\. Thrombocytopenia (platelet count of less than 100,000/µL)
- •6\. Known International Normalized Ratio (INR) greater than 1\.5 at screening.
- •7\. Requirement for dialysis treatment (hemodialysis or peritoneal)
- •8\. Estimated Glomeular filtration rate eGFR \<30 ml/min
- •9\. Administration of abciximab within 24 hours of randomization or administration of
- •eptifibitide or tirofiban within 12 hours of randomization.
Outcomes
Primary Outcomes
Not specified
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