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Completed

NCT Number: NCT02668562

Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early CABG (Day 2-3 after ticagrelor discontinuation)

Procedure

Timing for CABG after ticagrelor discontinuation

Delayed CABG (Day 5-7 after ticagrelor discontinuation)

Procedure

Timing for CABG after ticagrelor discontinuation

Primary outcomes

  1. Severe-massive bleeding

    Time frame: 24 hours post CABG

    Class 3 or 4 UDPB (universal definition for peri-operative bleeding)

  2. 12-hour chest tube drainage

    Time frame: 12 hours post CABG

    Chest tube drainage in the first 12 hours after bypass surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Acronym: RAPID CABG

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2016
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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