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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PRU guided CABG

Intervention Type PROCEDURE

Coronary Artery Bypass Surgery

VerifyNow assay

Intervention Type DEVICE

Platelet reactivity Units by VerifyNow assay

Ticagrelor

Intervention Type DRUG

Ticagrelor administration prior to randomization

CABG per standard of care

Timing of CABG per standard of care

Group Type ACTIVE_COMPARATOR

CABG per standard of care

Intervention Type PROCEDURE

Coronary Artery Bypass Surgery

VerifyNow assay

Intervention Type DEVICE

Platelet reactivity Units by VerifyNow assay

Ticagrelor

Intervention Type DRUG

Ticagrelor administration prior to randomization

Interventions

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PRU guided CABG

Coronary Artery Bypass Surgery

Intervention Type PROCEDURE

CABG per standard of care

Coronary Artery Bypass Surgery

Intervention Type PROCEDURE

VerifyNow assay

Platelet reactivity Units by VerifyNow assay

Intervention Type DEVICE

Ticagrelor

Ticagrelor administration prior to randomization

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No