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

Primary Purpose

Multi Vessel Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multi Vessel Coronary Artery Disease focused on measuring Antiplatelets, Coronary artery bypass surgery

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Outcomes

Primary Outcome Measures

Early graft patency
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

degree of resistance
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.
Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay
The cut-off PRU value was 188 PRU
Mediastinal Bleeding
total drainage counts (ml) from median tubes
Total hospital day from admission to discharge
rate of postoperative stroke of myocardial infarction
rate of postoperative morbidity/ mortality

Full Information

First Posted
August 20, 2021
Last Updated
December 20, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05166538
Brief Title
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass
Official Title
Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Vessel Coronary Artery Disease
Keywords
Antiplatelets, Coronary artery bypass surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Title
Clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
brilinta
Intervention Description
direct-acting oral P2Y12-receptor antagonist
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
plavix
Intervention Description
platelet aggregation inhibitor
Primary Outcome Measure Information:
Title
Early graft patency
Description
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.
Time Frame
1 year after OPCAB
Secondary Outcome Measure Information:
Title
degree of resistance
Description
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.
Time Frame
7 day after surgery
Title
Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay
Description
The cut-off PRU value was 188 PRU
Time Frame
7 day after surgery
Title
Mediastinal Bleeding
Description
total drainage counts (ml) from median tubes
Time Frame
up to 4 weeks
Title
Total hospital day from admission to discharge
Time Frame
up to 4 weeks
Title
rate of postoperative stroke of myocardial infarction
Time Frame
Participants will be followed during 1 years from operation
Title
rate of postoperative morbidity/ mortality
Time Frame
Participants will be followed during 5 years from operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged 19 years or older undergoing elective OPCAB surgery with multi-vessel coronary artery disease. Exclusion Criteria: 1) patient had aspirin resistance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Nam Youn
Phone
82-10-9930-4522
Email
ysgs@yuhs.ac
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33442205
Citation
Varma PK, Ahmed H, Krishna N, Jose R, Gopal K, Mathew OP, Jayant A. Bleeding complications after dual antiplatelet therapy with ticagrelor versus dual antiplatelet therapy with clopidogrel-a propensity-matched comparative study of two antiplatelet regimes in off-pump coronary artery bypass grafting. Indian J Thorac Cardiovasc Surg. 2021 Jan;37(1):27-37. doi: 10.1007/s12055-020-01052-6. Epub 2020 Oct 7.
Results Reference
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Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass

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