Clinical trial NCT05166538: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multi Vessel Coronary Artery Disease
Keywords: Antiplatelets
Coronary artery bypass surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early graft patency
timeFrame: 1 year after OPCAB
Secondary outcomes:
measure: degree of resistance
timeFrame: 7 day after surgery
measure: Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay
timeFrame: 7 day after surgery
measure: Mediastinal Bleeding
timeFrame: up to 4 weeks
measure: Total hospital day from admission to discharge
timeFrame: up to 4 weeks
measure: rate of postoperative stroke of myocardial infarction
timeFrame: Participants will be followed during 1 years from operation
measure: rate of postoperative morbidity/ mortality
timeFrame: Participants will be followed during 5 years from operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
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.