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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627521
Acronym
CABG-TIME
Enrollment
260
Registered
2015-12-11
Start date
2015-07-31
Completion date
2017-08-31
Last updated
2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGTicagrelor

Ticagrelor administration prior to randomization

PROCEDURECABG per standard of care

Coronary Artery Bypass Surgery

DEVICEVerifyNow assay

Platelet reactivity Units by VerifyNow assay

PROCEDUREPRU guided CABG

Coronary Artery Bypass Surgery

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayup to 30 dayThe primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups

Countries

Canada

Contacts

Primary ContactAsim Cheema, MD
cheemaa@smh.ca4168645739
Backup ContactIshba Syed, MBBS
syedi@smh.ca4168646060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026