Maintenance of Platelet Inhibition With Cangrelor

Phase 2

Completed

• Conditions: Acute Coronary Syndrome (ACS)
• Interventions: Drug: cangrelor; Other: Placebo

• Registration Number: NCT00767507
• Lead Sponsor: The Medicines Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Results First Submitted: 2013-04-23
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-21
• Last Update Submitted: 2014-02-21
• Results First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cangrelor	cangrelor	Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Placebo	Placebo	A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.

Primary Outcome Measures

Name	Time	Method
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.	During study drug infusion up to 1-6 hours prior to surgery	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).
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.	During study drug infusion up to 1-6 hours prior to 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.

Secondary Outcome Measures

Name	Time	Method
Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU	baseline until just prior to surgery (post infusion)	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
Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding	Randomization through Hospital discharge	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
Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild	Randomization until start of CABG surgery
Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner	Through 7 days or hospital discharge, whichever was sooner

Trial Locations

Locations (1)

Scripps Clinic / Scripps Green Hospital; 🇺🇸 La Jolla, California, United States