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CompletedNCT02668562RAPID CABGUpdated Oct 26, 2023

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

An interventional study of Early CABG (Day 2-3 after ticagrelor discontinuation) and Delayed CABG (Day 5-7 after ticagrelor discontinuation) in Acute Coronary Syndrome, sponsored by Ottawa Heart Institute Research Corporation. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • acute coronary syndrome
  • coronary artery bypass surgery
  • ticagrelor
  • antiplatelet therapy
  • platelet function testing
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 143 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    Early CABG

    Patients to undergo early CABG

    Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)

  • Active comparator
    Delayed CABG

    Patients to undergo delayed CABG

    Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Interventions

  • ProcedureEarly CABG (Day 2-3 after ticagrelor discontinuation)

    Timing for CABG after ticagrelor discontinuation

  • ProcedureDelayed CABG (Day 5-7 after ticagrelor discontinuation)

    Timing for CABG after ticagrelor discontinuation

06

What researchers measure

Primary outcomes

  1. Severe-massive bleeding

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

    Time frame: 24 hours post CABG

  2. 12-hour chest tube drainage

    Chest tube drainage in the first 12 hours after bypass surgery

    Time frame: 12 hours post CABG

Secondary outcomes

  1. Other major bleeding criteria (BARC)

    Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding

    Time frame: 48 hours post CABG

  2. Other major bleeding criteria (TIMI)

    TIMI major/minor CABG bleeding

    Time frame: 48 hours post CABG

  3. Other major bleeding criteria (CABG related life threatening bleed)

    CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding

    Time frame: 48 hours post CABG

  4. Transfusion (RBC)

    Red Blood Cell (RBC) transfusion (in Units)

    Time frame: 48 hours post CABG

  5. Transfusion (Platelet)

    Platelet transfusion (in Units)

    Time frame: 48 hours post CABG

  6. Peri-operative biomarker rise

    CK, troponin rise post CABG

    Time frame: 48 hours post CABG

  7. 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

    Time frame: 6 months and 1 year

  8. 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

    Time frame: 6 months and 1 year

  9. P2Y12 Reactivity Units (PRU) as a continuous variable

    Platelet Function as Measured by VerifyNow P2Y12 assay

    Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG

  10. ADP-induced Aggregation (AU) as a continuous variable

    Platelet Function as Measured by Multiplate analyzer

    Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG

07

Study locations

2 sites
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y4W7, Canada
  • Montreal Heart Institute
    Montreal, Quebec H1T1C8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02668562
Lead sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Feb 2016
Primary completion
Apr 9, 2021
Completion
Mar 9, 2022
Last update
Oct 26, 2023

Study contacts

Derek So, MD FRCPC FACC
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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