A Phase 4 interventional study of Ticagrelor and Clopidogrel in Multi Vessel Coronary Artery Disease, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-12-22.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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.
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.
Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1) patient had aspirin resistance
Drug: Ticagrelor
Drug: Clopidogrel
direct-acting oral P2Y12-receptor antagonist
Also known as: brilinta
platelet aggregation inhibitor
Also known as: plavix
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.
Time frame: 1 year after OPCAB
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.
Time frame: 7 day after surgery
Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay
The cut-off PRU value was 188 PRU
Time frame: 7 day after surgery
Mediastinal Bleeding
total drainage counts (ml) from median tubes
Time frame: up to 4 weeks
Total hospital day from admission to discharge
Time frame: up to 4 weeks
rate of postoperative stroke of myocardial infarction
Time frame: Participants will be followed during 1 years from operation
rate of postoperative morbidity/ mortality
Time frame: Participants will be followed during 5 years from operation
Plan to share: No
Start is estimated for Feb 2022; primary completion for Dec 2023, 22 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ticagrelor