Maintenance of Platelet Inhibition With Cangrelor (Bridge)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00767507
First received: October 6, 2008
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome (ACS)
Drug: cangrelor
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • 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. [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ] [ Designated as safety issue: No ]
    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. [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ] [ Designated as safety issue: No ]

    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:
  • Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU [ Time Frame: baseline until just prior to surgery (post infusion) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Randomization through Hospital discharge ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Randomization until start of CABG surgery ] [ Designated as safety issue: Yes ]
  • Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner [ Time Frame: Through 7 days or hospital discharge, whichever was sooner ] [ Designated as safety issue: Yes ]

Enrollment: 221
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: cangrelor
Placebo Comparator: 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.
Other: Placebo
Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767507

Locations
United States, California
Scripps Clinic / Scripps Green Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Eric Topol, MD Scripps
  More Information

No publications provided by The Medicines Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00767507     History of Changes
Other Study ID Numbers: TMC-CAN-08-02
Study First Received: October 6, 2008
Results First Received: April 23, 2013
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Cangrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014