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Optimizing Timing of CABG in Patients Presenting With ACS and Treated With Ticagrelor (CABG-TIME)

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ClinicalTrials.gov Identifier: NCT02627521
Recruitment Status : Unknown
Verified February 2017 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : December 11, 2015
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: PRU guided CABG Procedure: CABG per standard of care Device: VerifyNow assay Drug: Ticagrelor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Timing of Coronary Artery Bypass Surgery in Patients Presenting With Acute Coronary Syndrome and Treated With Second Generation ADP Receptor Antagonist
Study Start Date : July 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
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.
Procedure: PRU guided CABG
Coronary Artery Bypass Surgery

Device: VerifyNow assay
Platelet reactivity Units by VerifyNow assay

Drug: Ticagrelor
Ticagrelor administration prior to randomization

Active Comparator: CABG per standard of care
Timing of CABG per standard of care
Procedure: CABG per standard of care
Coronary Artery Bypass Surgery

Device: VerifyNow assay
Platelet reactivity Units by VerifyNow assay

Drug: Ticagrelor
Ticagrelor administration prior to randomization




Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: up to 30 day ]
    The primary efficacy endpoint of the study is the total length of hospital stay (LOS) for CABG surgery between the two groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627521


Contacts
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Contact: Asim Cheema, MD 4168645739 cheemaa@smh.ca
Contact: Ishba Syed, MBBS 4168646060 ext 77191 syedi@smh.ca

Locations
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Canada, Ontario
St. Michael's hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Asim Cheema, MD    416-864-5739    cheemaA@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Asim Cheema, MD, PhD St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02627521     History of Changes
Other Study ID Numbers: REB#13-287
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs