Maintenance of Platelet Inhibition With Cangrelor

Acute Coronary Syndrome (ACS) Clinical Trial

— Bridge  

Official title:

BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767507
• Other study ID #: TMC-CAN-08-02
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2008
• Last updated: February 21, 2014
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2014
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)

Intervention

Drug:
• cangrelor

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

Locations

Country	Name	City	State
United States	Scripps Clinic / Scripps Green Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	During study drug infusion up to 1-6 hours prior to surgery	No
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.	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.	During study drug infusion up to 1-6 hours prior to surgery	No
Secondary	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	baseline until just prior to surgery (post infusion)	No
Secondary	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	Randomization through Hospital discharge	Yes
Secondary	Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild		Randomization until start of CABG surgery	Yes
Secondary	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	Yes