Subjects who present with an acute coronary syndrome. MedDRA version: 12.0 Level: LLT Classification code 10051592 Term: Acute coronary syndrome MedDRA version: 12.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome MedDRA version: 12.0 Level: LLT Classification code 10006894 Term: CABG
Conditions
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion 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 500 mg ticlopidine, or 10mg prasugrel) within 72 hours prior to enrollment in the study for either: 1. the treatment of an acute coronary syndrome, regardless of time from ACS, and/or 2. as long-term preventative therapy following drug-eluting or bare metal 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
Exclusion criteria
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. 10. Plans to continue oral anticoagulant, thienopyridine or GPIIb/IIIa antagonist therapy in the pre-operative period. 11. Known or suspected coagulopathy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Stage I The primary objective of the open-label Stage I portion of this study is to identify a dose of cangrelor (between 0.5 µg/kg/min and 2.0 µg/kg/min) that achieves and maintains > 60% platelet inhibition in at least 80% of samples as determined by the Accumetrics VerifyNow™ P2Y12 assay in patients who have discontinued thienopyridine therapy. Stage II The primary efficacy objective of Stage II in this study is to demonstrate that a cangrelor infusion (as determined in Stage I) will maintain levels of residual platelet reactivity (PRU < 240) as measured by Accumetrics VerifyNow™ P2Y12 assay. This level is the equivalent to those levels expected to be maintained if a thienopyridine (clopidogrel, ticlopidine or prasugrel) had not been discontinued. ;Secondary Objective: The main safety objective is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.;Primary end point(s): Stage I: Open label lead-in period: The primary endpoint is maintenance of platelet inhibition in at least 80% of patient samples above 60% as determined by VerifyNowTM P2Y12 point of care assay measured during study drug infusion prior to surgery. Stage II: Blinded, randomized period: The primary endpoint is the percentage of patients with PRU < 240 as determined by VerifyNowTM P2Y12 point of care assay measured during study drug infusion prior to surgery. | — |
Countries
Austria, Czech Republic, Netherlands, United Kingdom
Outcome results
None listed