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

NCT05166538 | Unknown Phase 4 DMC

• 1 other identifier: 2021-2374-001
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Multi Vessel Coronary Artery Disease

Keywords

Antiplatelets; Coronary artery bypass surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• degree of resistance

  7 day after surgery

• Number of patients with resistance with clopidogrel as assessed by VeriofyNowP2Y12 assay

  7 day after surgery

• Mediastinal Bleeding

  up to 4 weeks

• 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

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

direct-acting oral P2Y12-receptor antagonist

Also known as: brilinta

Ticagrelor

Clopidogrel DRUG

platelet aggregation inhibitor

Also known as: plavix

Clopidogrel

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 19 years or older
• undergoing elective OPCAB surgery with multi-vessel coronary artery disease.

You may not qualify if:

• \) patient had aspirin resistance

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Related 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.

  PMID: 33442205 BACKGROUND

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Young-Nam Youn

CONTACT

82-10-9930-4522; ysgs@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Postoperative cardiac surgery, patients were randomized to receive ticagrelor or clopidogrel (n=102), respectively. The selected agent was applied in the operating room.

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: December 22, 2021
• Study Start: February 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)