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

Phase 4

• Conditions: Multi Vessel Coronary Artery Disease
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT05166538
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2021-08-20
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2021-12-22
• Last Update Posted: 2021-12-22
• Study Start: 2022-02-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay	7 day after surgery	The cut-off PRU value was 188 PRU
Mediastinal Bleeding	up to 4 weeks	total drainage counts (ml) from median tubes
Total hospital day from admission to discharge	up to 4 weeks
rate of postoperative stroke of myocardial infarction	Participants will be followed during 1 years from operation
rate of postoperative morbidity/ mortality	Participants will be followed during 5 years from operation

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of