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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation); Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)

• Registration Number: NCT02668562
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-02
• Primary Completion: 2021-04-09
• Study Completion: 2022-03-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early CABG	Early CABG (Day 2-3 after ticagrelor discontinuation)	Patients to undergo early CABG
Delayed CABG	Delayed CABG (Day 5-7 after ticagrelor discontinuation)	Patients to undergo delayed CABG

Primary Outcome Measures

Name	Time	Method
Severe-massive bleeding	24 hours post CABG	Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
12-hour chest tube drainage	12 hours post CABG	Chest tube drainage in the first 12 hours after bypass surgery

Secondary Outcome Measures

Name	Time	Method
P2Y12 Reactivity Units (PRU) as a continuous variable	Baseline (at CABG), 24, 48, 72 hours post CABG	Platelet Function as Measured by VerifyNow P2Y12 assay
Other major bleeding criteria (BARC)	48 hours post CABG	Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
Other major bleeding criteria (TIMI)	48 hours post CABG	TIMI major/minor CABG bleeding
Other major bleeding criteria (CABG related life threatening bleed)	48 hours post CABG	CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
Transfusion (Platelet)	48 hours post CABG	Platelet transfusion (in Units)
Transfusion (RBC)	48 hours post CABG	Red Blood Cell (RBC) transfusion (in Units)
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).	6 months and 1 year	MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Peri-operative biomarker rise	48 hours post CABG	CK, troponin rise post CABG
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).	6 months and 1 year	cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
ADP-induced Aggregation (AU) as a continuous variable	Baseline (at CABG), 24, 48, 72 hours post CABG	Platelet Function as Measured by Multiplate analyzer

Trial Locations

Locations (2)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada