Maintenance of Platelet Inhibition With Cangrelor

The Medicines Company221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

221

Conditions

Acute Coronary Syndrome (ACS)

Interventions

cangrelorDRUG

PlaceboOTHER

Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Scripps Clinic / Scripps Green Hospital

La Jolla, California, United States

Outcomes

Primary Outcomes

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.

Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).

Time frame: During study drug infusion up to 1-6 hours prior to surgery

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.

This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events. Patients had multiple samples and all "on-infusion" samples had to be \<240 PRU to meet the endpoint.

Time frame: During study drug infusion up to 1-6 hours prior to surgery

Secondary Outcomes

Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU

This endpoint analyzed the percent of patients with platelet reactivity \< 240 PRU at the following timepoints: * Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition) * Last sample during infusion * Following discontinuation of study drug infusion

Time frame: baseline until just prior to surgery (post infusion)

Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding

Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of \>1.5 liters (L), and/or packed red blood cell transfusions \> 4 units

Time frame: Randomization through Hospital discharge

Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.