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Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05166538
Collaborator
(none)
204
Enrollment
1
Location
2
Arms
21.9
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ticagrelor, a direct-acting oral P2Y12-receptor antagonist, provides greater and more consistent platelet inhibition than clopidogrel. This study aimed to compare outcomes of ticagrelor plus aspirin versus clopidogrel plus aspirin 1 year after off-pump coronary artery bypass grafting (OPCAB) in patients with clopidogrel resistance.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Between November 2014 and November 2020, 1739 patients underwent OPCAB. Aspirin (100mg daily) and clopidogrel (75mg daily) were administered beginning at aday 1 after surgery. On the 7th postoperative day, the clopidogrel resistance was evaluated by point-of-care assay. Among them, the patients had clopidogrel resistance were enrolled in this study. Investigators divide them into two groups [A: ticagrelor, B; clopidogrel]. Primary endpoint was all-cause of mortality 1 year after OPCAB. Secondary endpoint included major adverse cardiovascular events (MACE: cardiac death, myocardial infarction, or stroke). Multivariate Cox regression was used to evaluate predictors of end points.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Postoperative cardiac surgery, patients were randomized to receive ticagrelor or clopidogrel (n=102), respectively. The selected agent was applied in the operating room.Postoperative cardiac surgery, patients were randomized to receive ticagrelor or clopidogrel (n=102), respectively. The selected agent was applied in the operating room.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ticagrelor

Drug: Ticagrelor
direct-acting oral P2Y12-receptor antagonist
Other Names:
  • brilinta

    		•
    Active Comparator: Clopidogrel

    Drug: Clopidogrel
    platelet aggregation inhibitor
    Other Names:
  • plavix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Early graft patency [1 year after OPCAB]

      graft occlusion rate diagnosed by CT exam, at follow-up angiography, grafts were evaluated by use of the usual definition of patency and were assessed for FitzGibbon patency with the A, B, and O classification system in which FitzGibbon A is an excellent/unimpaired graft, Bis an impaired graft with a stenosis >50% reducing the caliber of the graft to <50% of the target artery diameter, and O is a completely occluded graft.

    Secondary Outcome Measures

    1. degree of resistance [7 day after surgery]

      Platelet reactivity was assayed using the VeriofyNowP2Y12 assay (Accumetrics Inc, San Diego, CA) which is a cartridge-based assay that specifically measures the direct effects of clopidogrel on the platelet P2Y12 receptor. The results are expressed as P2Y12 reaction units (PRUs) for clopidogrel. The cut-off PRU value was 188 PRU and the details were described previous study.

    2. Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay [7 day after surgery]

      The cut-off PRU value was 188 PRU

    3. Mediastinal Bleeding [up to 4 weeks]

      total drainage counts (ml) from median tubes

    4. Total hospital day from admission to discharge [up to 4 weeks]

    5. rate of postoperative stroke of myocardial infarction [Participants will be followed during 1 years from operation]

    6. rate of postoperative morbidity/ mortality [Participants will be followed during 5 years from operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. patients aged 19 years or older

    2. undergoing elective OPCAB surgery with multi-vessel coronary artery disease.

    Exclusion Criteria:
    1. patient had aspirin resistance

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05166538
    Other Study ID Numbers:
    • 2021-2374-001
    First Posted:
    Dec 22, 2021
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yonsei University
    Antiplatelets
    Coronary artery bypass surgery
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Clopidogrel
    Ticagrelor

    Study Results

    No Results Posted as of Dec 22, 2021