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

U

University of Ottawa Heart Institute

Status

Completed

Conditions

Acute Coronary Syndrome

Treatments

Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)
Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Study type

Interventional

Funder types

Other

Identifiers

NCT02668562
20150656

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

143 participants in 2 patient groups

Early CABG
Experimental group
Description:
Patients to undergo early CABG
Treatment:
Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)
Delayed CABG
Active Comparator group
Description:
Patients to undergo delayed CABG
Treatment:
Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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