Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Procedure: CABG per standard of care; Procedure: PRU guided CABG; Device: VerifyNow assay; Drug: Ticagrelor

• Registration Number: NCT02627521
• Lead Sponsor: Unity Health Toronto

Brief Summary

The administration of Ticagrelor have demonstrated superiority to Clopidogrel in patients presenting with acute coronary syndrome (ACS) and remains a first line therapy as an adjunct to aspirin for patients admitted with ACS. The patient population treated with Ticagrelor at an early time point includes non ST elevation myocardial (NSTEMI) patients and those undergoing primary angioplasty for ST elevation myocardial infarction (STEMI). It is estimated that 10-15% of patients presenting with ACS have advanced coronary artery disease requiring Coronary Artery Bypass Surgery (CABG). The treatment guidelines recommend a delay of 5-7 days for CABG surgery in these patients for normalization of Ticagrelor induced platelet inhibition to reduce the risk of peri-operative bleeding. This delay may expose these high risk patients to adverse cardiac events while waiting for Ticagrelor effect to wean off. Furthermore, this empirical application of 5-7 day delay in all patients may be unnecessary due to the significant inter individual variability in response to Ticagrelor. There is limited data to determine the optimum timing of CABG surgery in ACS patients treated with Ticagrelor. The present study will determine the optimum timing of CABG in ACS patients treated with a loading and/or maintenance dose of Ticagrelor.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Accepted for CABG surgery
• Treatment with Ticagrelor within 48 hours

Exclusion Criteria

• Anticoagulation therapy
• Prior CABG.
• Active bleeding or at high risk of bleeding
• Severe liver or renal disease.
• Hypersensitivity to ticagrelor
• History of intracranial hemorrhage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG per standard of care	CABG per standard of care	Timing of CABG per standard of care
PRU Guided CABG	PRU guided CABG	Timing of CABG surgery within 24 hours of reaching a normalized platelet function (NPF). NPF defined as a PRU value \>235 or a PRU value between \>170 and \<235 for two consecutive days as documented by VerifyNow assay.
PRU Guided CABG	VerifyNow assay	Timing of CABG surgery within 24 hours of reaching a normalized platelet function (NPF). NPF defined as a PRU value \>235 or a PRU value between \>170 and \<235 for two consecutive days as documented by VerifyNow assay.
PRU Guided CABG	Ticagrelor	Timing of CABG surgery within 24 hours of reaching a normalized platelet function (NPF). NPF defined as a PRU value \>235 or a PRU value between \>170 and \<235 for two consecutive days as documented by VerifyNow assay.
CABG per standard of care	VerifyNow assay	Timing of CABG per standard of care
CABG per standard of care	Ticagrelor	Timing of CABG per standard of care

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	up to 30 day	The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups

Trial Locations

Locations (1)

St. Michael's hospital; 🇨🇦 Toronto, Ontario, Canada