Maintenance of platelet inhiBition with cangreloR after dIscontinuation ofthienopyriDines in patients undergoing surGEry: The BRIDGE trial - BRIDGE

The Medicines Company0 个研究点目标入组 220 人开始时间: 2010年6月28日最近更新: 2012年3月19日

试验速览

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•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.
•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

•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.
•10. Plans to continue oral anticoagulant, thienopyridine or GPIIb/IIIa antagonist therapy
•in the pre-operative period.
•11. Need of planned concomitant valvular heart surgery
•12. Refusal to receive blood transfusion
•13. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
•14. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or
•microcrystalline cellulose
•15. High likelihood of being unavailable for follow-up
•16. Participation in other clinical research studies involving the evaluation of other
•investigational drugs or devices within 30 days of randomization
•17. Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial

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