Phase 2
N=221
Maintenance of Platelet Inhibition With Cangrelor
Acute Coronary Syndrome (ACS)
Bottom Line
View on ClinicalTrials.gov: NCT00767507 ↗Enrolled (actual)
221
Serious AEs
9.2%
Results posted
Apr 2014
Primary outcome: Primary: Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay. — 76.5; 94.4 percentage of samples
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cangrelor (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Medicines Company
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay. |
76.5; 94.4 | — |
| PRIMARY Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery. |
98.8; 19.0 | — |
| SECONDARY Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU |
62.4; 52.3; 98.8; 31.0; 26.9; 20.0 | — |
| SECONDARY Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding |
12; 10; 0; 1 | — |
| SECONDARY Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild |
2; 1; 0; 0; 10; 4 | — |
| SECONDARY Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner |
34; 35; 1; 4 | — |
Summary
The purpose of this study 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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- 18 Years of Age
- Non emergent coronary bypass graft surgery
- Received a thienopyridine within 48 hours prior to enrollment
Exclusion Criteria
- Confirmed or suspected pregnancy
- Cerebrovascular accident within one yar
- Intracranial neoplasm
- History of bleeding diathesis
- Thrombocytopenia
Data sourced from ClinicalTrials.gov (NCT00767507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.