A Phase 4 interventional study of PRU guided CABG and CABG per standard of care in Coronary Artery Disease, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 260 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: VerifyNow assay · Drug: Ticagrelor
Timing of CABG per standard of care
Procedure: CABG per standard of care · Device: VerifyNow assay · Drug: Ticagrelor
Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery
Platelet reactivity Units by VerifyNow assay
Ticagrelor administration prior to randomization
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
Time frame: up to 30 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto