NCT00767507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 4, 2014

Completed
Last Updated

April 4, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

October 6, 2008

Results QC Date

April 23, 2013

Last Update Submit

February 21, 2014

Conditions

Acute Coronary Syndrome (ACS)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

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

    baseline until just prior to surgery (post infusion)

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

    Randomization through Hospital discharge

  • 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

Study Arms (2)

Cangrelor

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

cangrelorDRUG
Cangrelor
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Years of Age
  • Non emergent coronary bypass graft surgery
  • Received a thienopyridine within 48 hours prior to enrollment

You may not qualify if:

  • Confirmed or suspected pregnancy
  • Cerebrovascular accident within one yar
  • Intracranial neoplasm
  • History of bleeding diathesis
  • Thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic / Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial. JAMA. 2012 Jan 18;307(3):265-74. doi: 10.1001/jama.2011.2002.

    PMID: 22253393DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Meredith Todd - Sr. Director Program Management
Organization
The Medicines Company
meredith.todd@themedco.com
+1.973.290.6088

Study Officials

  • Eric Topol, MD

    Scripps

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

April 4, 2014

Results First Posted

April 4, 2014

Record last verified: 2014-02

Locations

US(1)