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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: PRU guided CABG
* Procedure: CABG per standard of care
* Device: VerifyNow assay
* Drug: Ticagrelor


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRU Guided CABG<br>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. | Procedure: PRU guided CABG<br>* Coronary Artery Bypass Surgery<br>Device: VerifyNow assay<br>* Platelet reactivity Units by VerifyNow assay<br>Drug: Ticagrelor<br>* Ticagrelor administration prior to randomization<br>|
| Active Comparator: CABG per standard of care<br>Timing of CABG per standard of care | Procedure: CABG per standard of care<br>* Coronary Artery Bypass Surgery<br>Device: VerifyNow assay<br>* Platelet reactivity Units by VerifyNow assay<br>Drug: Ticagrelor<br>* Ticagrelor administration prior to randomization<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups | up to 30 day |