Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor (CABG-TIME)

Unity Health Toronto

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: VerifyNow assay; Procedure: CABG per standard of care; Procedure: PRU guided CABG; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02627521

REB#13-287

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

PRU Guided CABG

Experimental group

Description:

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.

Treatment:

Drug: Ticagrelor

Procedure: PRU guided CABG

Device: VerifyNow assay

CABG per standard of care

Active Comparator group

Description:

Timing of CABG per standard of care

Treatment:

Drug: Ticagrelor

Procedure: CABG per standard of care

Device: VerifyNow assay