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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2022-03-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Early CABG

Patients to undergo early CABG

Group Type EXPERIMENTAL

Early CABG (Day 2-3 after ticagrelor discontinuation)

Intervention Type PROCEDURE

Timing for CABG after ticagrelor discontinuation

Delayed CABG

Patients to undergo delayed CABG

Group Type ACTIVE_COMPARATOR

Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Intervention Type PROCEDURE

Timing for CABG after ticagrelor discontinuation

Interventions

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Early CABG (Day 2-3 after ticagrelor discontinuation)

Timing for CABG after ticagrelor discontinuation

Intervention Type PROCEDURE

Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Timing for CABG after ticagrelor discontinuation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No