Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
Timing for CABG after ticagrelor discontinuation
Timing for CABG after ticagrelor discontinuation
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Severe-massive bleeding
Class 3 or 4 UDPB (universal definition for peri-operative bleeding)
Time frame: 24 hours post CABG
12-hour chest tube drainage
Chest tube drainage in the first 12 hours after bypass surgery
Time frame: 12 hours post CABG
Other major bleeding criteria (BARC)
Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding
Time frame: 48 hours post CABG
Other major bleeding criteria (TIMI)
TIMI major/minor CABG bleeding
Time frame: 48 hours post CABG
Other major bleeding criteria (CABG related life threatening bleed)
CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding
Time frame: 48 hours post CABG
Transfusion (RBC)
Red Blood Cell (RBC) transfusion (in Units)
Time frame: 48 hours post CABG
Transfusion (Platelet)
Platelet transfusion (in Units)
Time frame: 48 hours post CABG
Peri-operative biomarker rise
CK, troponin rise post CABG
Time frame: 48 hours post CABG
Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Time frame: 6 months and 1 year
Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial).
cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization
Time frame: 6 months and 1 year
P2Y12 Reactivity Units (PRU) as a continuous variable
Platelet Function as Measured by VerifyNow P2Y12 assay
Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG
ADP-induced Aggregation (AU) as a continuous variable
Platelet Function as Measured by Multiplate analyzer
Time frame: Baseline (at CABG), 24, 48, 72 hours post CABG
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