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

Multi Vessel Coronary Artery Disease Clinical Trial

Official title:

Dual Antiplatelet Therapy in Patients With Clopidogrel Resistance Following Off-Pump Coronary Artery Bypass: Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05166538
• Other study ID #: 2021-2374-001
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2021
• Source: Yonsei University
• Contact: Young-Nam Youn
• Phone: 82-10-9930-4522
• Email: ysgs[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Multi Vessel Coronary Artery Disease

Intervention

Drug:
• Ticagrelor
direct-acting oral P2Y12-receptor antagonist
• Clopidogrel
platelet aggregation inhibitor

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

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