Recruiting

CABG with Ticagrelor

Sponsor:

Unity Health Toronto

Code:

NCT02627521

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRU guided CABG

CABG per standard of care

VerifyNow assay

Ticagrelor

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT02627521

Start date

Jul, 2015

Status verified date

Feb, 2017

Completion date

Aug, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRU Guided CABG

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.

active comparator: CABG per standard of care

Timing of CABG per standard of care

Interventions

PRU guided CABG

Coronary Artery Bypass Surgery

CABG per standard of care

Coronary Artery Bypass Surgery

VerifyNow assay

Platelet reactivity Units by VerifyNow assay

Ticagrelor

Ticagrelor administration prior to randomization

Primary outcome measure

  • Length of hospital stay [ Time Frame: up to 30 day ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

More Information

Sponsor

Unity Health Toronto

Last update posted

Feb 16, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2017-02-16.