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

NCT02627521 | Unknown Phase 4 DMC

• 1 other identifier: REB#13-287
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups

  up to 30 day

Study Arms (2)

PRU Guided CABG

EXPERIMENTAL

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.

Procedure: PRU guided CABG; Device: VerifyNow assay; Drug: Ticagrelor

CABG per standard of care

ACTIVE COMPARATOR

Timing of CABG per standard of care

Procedure: CABG per standard of care; Device: VerifyNow assay; Drug: Ticagrelor

Interventions

PRU guided CABG PROCEDURE

Coronary Artery Bypass Surgery

PRU Guided CABG

CABG per standard of care PROCEDURE

Coronary Artery Bypass Surgery

CABG per standard of care

VerifyNow assay DEVICE

Platelet reactivity Units by VerifyNow assay

CABG per standard of care; PRU Guided CABG

Ticagrelor DRUG

Ticagrelor administration prior to randomization

CABG per standard of care; PRU Guided CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted for CABG surgery
• Treatment with Ticagrelor within 48 hours

You may not qualify if:

• Anticoagulation therapy
• Prior CABG.
• Active bleeding or at high risk of bleeding
• Severe liver or renal disease.
• Hypersensitivity to ticagrelor
• History of intracranial hemorrhage

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Asim Cheema, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asim Cheema, MD

CONTACT

4168645739; cheemaa@smh.ca

Ishba Syed, MBBS

CONTACT

4168646060; syedi@smh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

CA (1)