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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRU Guided CABG | Experimental | 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 | Active Comparator | Timing of CABG per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRU guided CABG | Procedure | Coronary Artery Bypass Surgery |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asim Cheema, MD | Contact | 4168645739 | cheemaa@smh.ca | |
| Ishba Syed, MBBS | Contact | 4168646060 | 77191 | syedi@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Asim Cheema, MD, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| CABG per standard of care |
| Procedure |
Coronary Artery Bypass Surgery |
|
| VerifyNow assay | Device | Platelet reactivity Units by VerifyNow assay |
|
| Ticagrelor | Drug | Ticagrelor administration prior to randomization |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |