NCT02668562

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 6, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

5.2 years

First QC Date

January 6, 2016

Last Update Submit

October 23, 2023

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndromecoronary artery bypass surgeryticagrelorantiplatelet therapyplatelet function testing

Outcome Measures

Primary Outcomes (2)

  • Severe-massive bleeding

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

    24 hours post CABG

  • 12-hour chest tube drainage

    Chest tube drainage in the first 12 hours after bypass surgery

    12 hours post CABG

Secondary Outcomes (10)

  • Other major bleeding criteria (BARC)

    48 hours post CABG

  • Other major bleeding criteria (TIMI)

    48 hours post CABG

  • Other major bleeding criteria (CABG related life threatening bleed)

    48 hours post CABG

  • Transfusion (RBC)

    48 hours post CABG

  • Transfusion (Platelet)

    48 hours post CABG

  • +5 more secondary outcomes

Study Arms (2)

Early CABG

EXPERIMENTAL

Patients to undergo early CABG

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

Delayed CABG

ACTIVE COMPARATOR

Patients to undergo delayed CABG

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

Interventions

Early CABG (Day 2-3 after ticagrelor discontinuation)PROCEDURE

Timing for CABG after ticagrelor discontinuation

Early CABG
Delayed CABG (Day 5-7 after ticagrelor discontinuation)PROCEDURE

Timing for CABG after ticagrelor discontinuation

Delayed CABG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Related Publications (1)

  • So DYF, Wells GA, Lordkipanidze M, Chong AY, Ruel M, Perrault LP, Le May MR, Sun L, Tran D, Labinaz M, Glover C, Russo J, Welman M, Chan V, Chen L, Bernick J, Rubens F, Tanguay JF; RAPID CABG Investigators. Early vs Delayed Bypass Surgery in Patients With Acute Coronary Syndrome Receiving Ticagrelor: The RAPID CABG Randomized Open-Label Noninferiority Trial. JAMA Surg. 2025 Apr 1;160(4):387-394. doi: 10.1001/jamasurg.2024.7066.

    PMID: 39969871DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Derek So, MD FRCPC FACC

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 29, 2016

Study Start

February 1, 2016

Primary Completion

April 9, 2021

Study Completion

March 9, 2022

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)