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Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor (RAPID CABG)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early CABG (Day 2-3 after ticagrelor discontinuation)
Delayed CABG (Day 5-7 after ticagrelor discontinuation)
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, coronary artery bypass surgery, ticagrelor, antiplatelet therapy, platelet function testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made

Exclusion Criteria:

Patients are excluded if they:

  • refuse consent for enrollment
  • are deemed to require immediate CABG (Day 0 or day 1)
  • have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI
  • are undergoing concurrent valve surgery
  • are intolerant or allergic to aspirin
  • have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)
  • received adjuvant therapy with a glycoprotein IIbIIIa inhibitor
  • have a co-morbidity with life-expectancy of < 1 year
  • have active bleeding

Sites / Locations

  • University of Ottawa Heart Institute
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early CABG

Delayed CABG

Arm Description

Patients to undergo early CABG

Patients to undergo delayed CABG

Outcomes

Primary Outcome Measures

Severe-massive bleeding
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)

Secondary Outcome Measures

Other major bleeding criteria (BARC)
Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
Other major bleeding criteria (TIMI)
TIMI major/minor CABG bleeding
Other major bleeding criteria (CABG related life threatening bleed)
CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
Transfusion (RBC)
Red Blood Cell (RBC) transfusion (in Units)
Transfusion (Platelet)
Platelet transfusion (in Units)
Peri-operative biomarker rise
CK, troponin rise post CABG
Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
P2Y12 Reactivity Units (PRU) as a continuous variable
Platelet Function as Measured by VerifyNow P2Y12 assay
ADP-induced Aggregation (AU) as a continuous variable
Platelet Function as Measured by Multiplate analyzer

Full Information

First Posted
January 6, 2016
Last Updated
April 25, 2022
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02668562
Brief Title
Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor
Acronym
RAPID CABG
Official Title
Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Complications - The RAPID-TITRATE CABG Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
March 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, coronary artery bypass surgery, ticagrelor, antiplatelet therapy, platelet function testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early CABG
Arm Type
Experimental
Arm Description
Patients to undergo early CABG
Arm Title
Delayed CABG
Arm Type
Active Comparator
Arm Description
Patients to undergo delayed CABG
Intervention Type
Procedure
Intervention Name(s)
Early CABG (Day 2-3 after ticagrelor discontinuation)
Intervention Description
Timing for CABG after ticagrelor discontinuation
Intervention Type
Procedure
Intervention Name(s)
Delayed CABG (Day 5-7 after ticagrelor discontinuation)
Intervention Description
Timing for CABG after ticagrelor discontinuation
Primary Outcome Measure Information:
Title
Severe-massive bleeding
Description
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
Time Frame
24 hours post CABG
Secondary Outcome Measure Information:
Title
Other major bleeding criteria (BARC)
Description
Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
Time Frame
48 hours post CABG
Title
Other major bleeding criteria (TIMI)
Description
TIMI major/minor CABG bleeding
Time Frame
48 hours post CABG
Title
Other major bleeding criteria (CABG related life threatening bleed)
Description
CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
Time Frame
48 hours post CABG
Title
Transfusion (RBC)
Description
Red Blood Cell (RBC) transfusion (in Units)
Time Frame
48 hours post CABG
Title
Transfusion (Platelet)
Description
Platelet transfusion (in Units)
Time Frame
48 hours post CABG
Title
Peri-operative biomarker rise
Description
CK, troponin rise post CABG
Time Frame
48 hours post CABG
Title
Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
Description
MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Time Frame
6 months and 1 year
Title
Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
Description
cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Time Frame
6 months and 1 year
Title
P2Y12 Reactivity Units (PRU) as a continuous variable
Description
Platelet Function as Measured by VerifyNow P2Y12 assay
Time Frame
Baseline (at CABG), 24, 48, 72 hours post CABG
Title
ADP-induced Aggregation (AU) as a continuous variable
Description
Platelet Function as Measured by Multiplate analyzer
Time Frame
Baseline (at CABG), 24, 48, 72 hours post CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made Exclusion Criteria: Patients are excluded if they: refuse consent for enrollment are deemed to require immediate CABG (Day 0 or day 1) have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI are undergoing concurrent valve surgery are intolerant or allergic to aspirin have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC) received adjuvant therapy with a glycoprotein IIbIIIa inhibitor have a co-morbidity with life-expectancy of < 1 year have active bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek So, MD FRCPC FACC
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor

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