Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG

NCT06981390 | Not Yet Recruiting DMC

• 1 other identifier: JDEYXWK2025146
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the impact of different durations of Ticagrelor-based dual antiplatelet therapy (DAPT) on saphenous vein graft (SVG) patency in patients undergoing coronary artery bypass grafting (CABG). A total of 300 patients will be randomly assigned to receive Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, 6 months, or 12 months, followed by aspirin monotherapy.The primary outcome is 1-year graft patency, assessed via coronary CT angiography. Secondary outcomes include bleeding events (BARC classification), major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. The study aims to determine the optimal DAPT duration to balance graft patency benefits and bleeding risks, ultimately guiding postoperative antiplatelet strategies for CABG patients.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting; Saphenous Vein; Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

• Saphenous Vein Graft (SVG) Patency at 12 Months

  SVG patency will be assessed using coronary CT angiography, defined as FitzGibbon Grade A (≤50% stenosis). The patency rates will be compared among the three groups receiving Ticagrelor-based DAPT for different durations (3 months, 6 months, or 12 months).

  12 months post-CABG

Secondary Outcomes (3)

• Bleeding Events

  Up to 12 months post-CABG

• MACCE episodes

  Within 1-year after CABG

• All-Cause Mortality

  Up to 12 months post-CABG

Study Arms (3)

3-Month DAPT Group

ACTIVE COMPARATOR

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy

Drug: Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)

6-Month DAPT Group

ACTIVE COMPARATOR

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy

Drug: Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)

12-Month DAPT Group

EXPERIMENTAL

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Drug: Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)

Interventions

Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy) DRUG

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy

Also known as: 3-Month DAPT

3-Month DAPT Group

Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy) DRUG

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy

Also known as: 6-Month DAPT

6-Month DAPT Group

Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy) DRUG

Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy

Also known as: 12-Month DAPT

12-Month DAPT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-80 of age.
• Patients undergo planned CABG for the first time with ≥1 SVGs
• Patients with written informed consent.

You may not qualify if:

• Patients undergoing concomitant valve surgery (excluding aortic bioprosthesis), aortic surgery, or rhythm surgery during the same session.
• Patients undergoing emergency CABG.
• Patients with single-vessel coronary artery disease.
• Patients with cardiogenic shock or hemodynamic instability.
• Patients with sick sinus syndrome, second- or third-degree atrioventricular block.
• Patients with contraindications for coronary computed tomography angiography (CCTA) or coronary angiography, including contrast media allergy.
• Patients requiring antiplatelet therapy other than aspirin or ticagrelor (e.g., clopidogrel, prasugrel) and unable to discontinue such medication after CABG, based on physician or investigator judgment.
• Patients on oral anticoagulants before CABG who must continue anticoagulation therapy postoperatively.
• Patients with contraindications for ticagrelor or aspirin, including:
• Bleeding diathesis within the past 3 months. 9.2Severe gastrointestinal bleeding within the past year. 9.3Peptic ulcer (even without bleeding) within the past 3 years. 9.4History of intracranial hemorrhage, aspirin allergy, or severe aspirin-induced gastrointestinal reaction.
• Patients with a drug-eluting stent (DES) in a coronary or cerebral artery within 6 months before CABG, or a bare-metal stent (BMS) within 1 month before CABG.
• Patients with thrombocytopenia (\<100 x 10⁹/L) before CABG.
• Patients with severe renal dysfunction requiring dialysis or active liver disease, including unexplained persistent transaminase elevation or transaminase levels \>3× the upper normal limit.
• Patients using strong CYP3A4 inhibitors.
• Patients requiring methotrexate and ibuprofen therapy.

Sponsors & Collaborators

• Kexiang Liu, MD: lead

Study Sites (1)

the Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Aspirin; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• kexiang liu

  Second Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

kexiang liu

CONTACT

17390920328; kxliu64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 20, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)