Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor (CABG-TIME)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
PRU guided CABG
CABG per standard of care
VerifyNow assay
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Accepted for CABG surgery
- Treatment with Ticagrelor within 48 hours
Exclusion Criteria:
- Anticoagulation therapy
- Prior CABG.
- Active bleeding or at high risk of bleeding
- Severe liver or renal disease.
- Hypersensitivity to ticagrelor
- History of intracranial hemorrhage
Sites / Locations
- St. Michael's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRU Guided CABG
CABG per standard of care
Arm Description
Timing of CABG surgery within 24 hours of reaching a normalized platelet function (NPF). NPF defined as a PRU value >235 or a PRU value between >170 and <235 for two consecutive days as documented by VerifyNow assay.
Timing of CABG per standard of care
Outcomes
Primary Outcome Measures
Length of hospital stay
The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups
Secondary Outcome Measures
Full Information
NCT ID
NCT02627521
First Posted
December 3, 2015
Last Updated
February 15, 2017
Sponsor
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02627521
Brief Title
Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor
Acronym
CABG-TIME
Official Title
Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at an early time point includes non ST elevation myocardial (NSTEMI) patients and those undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be unnecessary due to the significant inter individual variability in response to Ticagrelor. There is limited data to determine the optimum timing of CABG surgery in ACS patients treated with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients treated with a loading and/or maintenance dose of Ticagrelor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRU Guided CABG
Arm Type
Experimental
Arm Description
Timing of CABG surgery within 24 hours of reaching a normalized platelet function (NPF). NPF defined as a PRU value >235 or a PRU value between >170 and <235 for two consecutive days as documented by VerifyNow assay.
Arm Title
CABG per standard of care
Arm Type
Active Comparator
Arm Description
Timing of CABG per standard of care
Intervention Type
Procedure
Intervention Name(s)
PRU guided CABG
Intervention Description
Coronary Artery Bypass Surgery
Intervention Type
Procedure
Intervention Name(s)
CABG per standard of care
Intervention Description
Coronary Artery Bypass Surgery
Intervention Type
Device
Intervention Name(s)
VerifyNow assay
Intervention Description
Platelet reactivity Units by VerifyNow assay
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor administration prior to randomization
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups
Time Frame
up to 30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Accepted for CABG surgery
Treatment with Ticagrelor within 48 hours
Exclusion Criteria:
Anticoagulation therapy
Prior CABG.
Active bleeding or at high risk of bleeding
Severe liver or renal disease.
Hypersensitivity to ticagrelor
History of intracranial hemorrhage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asim Cheema, MD
Phone
4168645739
Email
cheemaa@smh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ishba Syed, MBBS
Phone
4168646060
Ext
77191
Email
syedi@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asim Cheema, MD, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asim Cheema, MD
Phone
416-864-5739
Email
cheemaA@smh.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor
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