NCT02627521

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

Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	PRU guided CABG	Coronary Artery Bypass Surgery
PROCEDURE	CABG per standard of care	Coronary Artery Bypass Surgery
DEVICE	VerifyNow assay	Platelet reactivity Units by VerifyNow assay
DRUG	Ticagrelor	Ticagrelor administration prior to randomization

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2015-12-11
• Last updated: 2017-02-16

Locations

1 site across 1 country: Canada