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Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor (RAPID CABG)

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ClinicalTrials.gov Identifier: NCT02668562
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation) Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reassessment of Anti-Platelet Therapy Using InDividualized Strategies -Ticagrelor in Patients With Acute Coronary Syndromes Treated by Coronary Artery Bypass Graft Surgery - A Pharmacodynamic and Clinical Study to Decrease Bleeding Risks and Ischemic Complications - The RAPID-TITRATE CABG Study
Actual Study Start Date : February 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: Early CABG
Patients to undergo early CABG
Procedure: Early CABG (Day 2-3 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation

Active Comparator: Delayed CABG
Patients to undergo delayed CABG
Procedure: Delayed CABG (Day 5-7 after ticagrelor discontinuation)
Timing for CABG after ticagrelor discontinuation




Primary Outcome Measures :
  1. Severe-massive bleeding [ Time Frame: 24 hours post CABG ]
    Class 3 or 4 UDPB (universal definition for peri-operative bleeding)


Secondary Outcome Measures :
  1. Other major bleeding criteria (BARC) [ Time Frame: 48 hours post CABG ]
    Bleeding Academic Research Consortium (BARC) CABG-related (Type 4) bleeding

  2. Other major bleeding criteria (TIMI) [ Time Frame: 48 hours post CABG ]
    TIMI major/minor CABG bleeding

  3. Other major bleeding criteria (CABG related life threatening bleed) [ Time Frame: 48 hours post CABG ]
    CABG-related life-threatening bleed including: cardiac tamponade, all intracranial bleeding

  4. Transfusion (RBC) [ Time Frame: 48 hours post CABG ]
    Red Blood Cell (RBC) transfusion (in Units)

  5. Transfusion (Platelet) [ Time Frame: 48 hours post CABG ]
    Platelet transfusion (in Units)

  6. Peri-operative biomarker rise [ Time Frame: 48 hours post CABG ]
    CK, troponin rise post CABG

  7. Number of Patients with Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial). [ Time Frame: 6 months and 1 year ]
    MACE defined as composite of cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization

  8. Number of Patients with Individual Components of Major Adverse Cardiovascular Events (MACE) (To be collected but blinded to investigators,as this data will be carried from the vanguard study into a future definitive clinical trial). [ Time Frame: 6 months and 1 year ]
    cardiovascular death, recurrent myocardial infarction, stroke, refractory ischemia, or urgent unplanned revascularization

  9. P2Y12 Reactivity Units (PRU) as a continuous variable [ Time Frame: Baseline (at CABG), 24, 48, 72 hours post CABG ]
    Platelet Function as Measured by VerifyNow P2Y12 assay

  10. ADP-induced Aggregation (AU) as a continuous variable [ Time Frame: Baseline (at CABG), 24, 48, 72 hours post CABG ]
    Platelet Function as Measured by Multiplate analyzer



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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:

  • ACS patient referred for CABG and have received >= 1 dose of ticagrelor before decision for CABG made

Exclusion Criteria:

Patients are excluded if they:

  • refuse consent for enrollment
  • are deemed to require immediate CABG (Day 0 or day 1)
  • have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI
  • are undergoing concurrent valve surgery
  • are intolerant or allergic to aspirin
  • have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)
  • received adjuvant therapy with a glycoprotein IIbIIIa inhibitor
  • have a co-morbidity with life-expectancy of < 1 year
  • have active bleeding

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): NCT02668562


Contacts
Contact: Derek So, MD FRCPC FACC 613-761-5387 DSo@ottawaheart.ca
Contact: Lyne Stuewe, BScN 613-761-4646 LStuewe@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Lyne Stuewe, BScN    613-761-4646    lstuewe@ottawaheart.ca   
Principal Investigator: Derek So, MD FRCPC FACC         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T1C8
Contact: George Gabor-Popa       George.Gabor-Popa@icm-mhi.org   
Principal Investigator: Jean-Francois Tanguay, MD FRCPC         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Derek So, MD FRCPC FACC Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02668562     History of Changes
Other Study ID Numbers: 20150656
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Heart Institute Research Corporation:
acute coronary syndrome
coronary artery bypass surgery
ticagrelor
antiplatelet therapy
platelet function testing

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs