Clinical trial NCT02668562: Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor
Official title: Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Complications - The RAPID-TITRATE CABG Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
coronary artery bypass surgery
ticagrelor
antiplatelet therapy
platelet function testing
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-01-29
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* ACS patient referred for CABG and have received \>= 1 dose of ticagrelor before decision for CABG made

Exclusion Criteria:

Patients are excluded if they:

* refuse consent for enrollment
* are deemed to require immediate CABG (Day 0 or day 1)
* have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI
* are undergoing concurrent valve surgery
* are intolerant or allergic to aspirin
* have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)
* received adjuvant therapy with a glycoprotein IIbIIIa inhibitor
* have a co-morbidity with life-expectancy of \< 1 year
* have active bleeding

Primary outcomes:
measure: Severe-massive bleeding
timeFrame: 24 hours post CABG
measure: 12-hour chest tube drainage
timeFrame: 12 hours post CABG
Secondary outcomes:
measure: Other major bleeding criteria (BARC)
timeFrame: 48 hours post CABG
measure: Other major bleeding criteria (TIMI)
timeFrame: 48 hours post CABG
measure: Other major bleeding criteria (CABG related life threatening bleed)
timeFrame: 48 hours post CABG
measure: Transfusion (RBC)
timeFrame: 48 hours post CABG
measure: Transfusion (Platelet)
timeFrame: 48 hours post CABG
measure: Peri-operative biomarker rise
timeFrame: 48 hours post CABG
measure: 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).
timeFrame: 6 months and 1 year
measure: 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).
timeFrame: 6 months and 1 year
measure: P2Y12 Reactivity Units (PRU) as a continuous variable
timeFrame: Baseline (at CABG), 24, 48, 72 hours post CABG
measure: ADP-induced Aggregation (AU) as a continuous variable
timeFrame: Baseline (at CABG), 24, 48, 72 hours post CABG
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Derek So, MD FRCPC FACC
role: PRINCIPAL_INVESTIGATOR
References: