Coronary Artery DiseaseNCT06981390
Ticagrelor-Based Dual Antiplatelet Therapy Duration in CABG
A study testing Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy), Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy) and Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy) in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Kexiang Liu, MD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Saphenous Vein
- What is being tested?
- Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy), Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy) and Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18-80 of age.
- Patients undergo planned CABG for the first time with ≥1 SVGs
- Patients with written informed consent.
Who cannot join
- 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.
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- 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:
- 9.1Bleeding 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.
- Patients with active malignant tumors with an increased risk of bleeding, as determined by the investigator.
- Pregnant or breastfeeding women, and those who have given birth within the past 90 days.
- Premenopausal women not using adequate contraception. Adequate contraception requires at least two reliable methods, including one barrier method.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Second Hospital of Jilin University
Changchun, Jilin, 130000
kexiang liu, Ph.D.
About this study
Official title: Ticagrelor-Based Dual Antiplatelet Therapy in Coronary Artery Bypass Grafting: A Randomized Clinical Trial on Graft Patency
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.
Read the detailed description
Coronary artery bypass grafting (CABG) is a widely used revascularization strategy for patients with complex coronary artery disease. However, the long-term patency of saphenous vein grafts (SVGs) remains a significant clinical concern, with graft occlusion being a major contributor to recurrent ischemic events. Dual antiplatelet therapy (DAPT), consisting of Ticagrelor and Aspirin, is commonly used to prevent thrombosis and improve graft patency, yet the optimal duration of DAPT post-CABG remains unclear. This randomized, double-blind, controlled trial aims to assess the effects of different DAPT durations on SVG patency and clinical outcomes in CABG patients. A total of 300 patients undergoing isolated CABG with at least one SVG will be enrolled and randomly assigned (1:1:1) 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 of the study is SVG patency at 12 months, assessed via coronary CT angiography, defined as FitzGibbon Grade A (≤50% stenosis). Secondary outcomes include bleeding events , major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. Patients will be followed at 3, 6, and 12 months postoperatively, undergoing clinical assessments, laboratory tests, and imaging evaluations to monitor graft patency, bleeding complications, and cardiovascular and cerebrovascular events. The study will provide critical data to determine the optimal duration of DAPT to maximize graft patency while minimizing bleeding risks, ultimately guiding personalized antiplatelet strategies in CABG patients.
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Saphenous Vein, Dual Antiplatelet Therapy
- Being tested
- Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy), Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy), Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)Drug
Also called 3-Month DAPT
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy
Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)Drug
Also called 6-Month DAPT
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy
Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)Drug
Also called 12-Month DAPT
Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 3-Month DAPT Group | Active comparator | Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy Receives: 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 Receives: 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 Receives: Drug: Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months post-CABG
Secondary outcomes (3)
Bleeding Events
Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.
Measured: Up to 12 months post-CABG
MACCE episodes
MACCE episodes within 1-year after CABG (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or revascularization), as defined by the American College of Cardiology and American Heart Association and judged by an independent Clinical Endpoint Committee blinded to treatment allocation
Measured: Within 1-year after CABG
All-Cause Mortality
Death from any cause occurring during the study period.
Measured: Up to 12 months post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 May 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexiang Liu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kexiang Liu, MD, Second Hospital of Jilin University
- Investigators
- kexiang liu, Study director, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981390
- Sponsor's protocol ID
- JDEYXWK2025146
- Status last verified
- Apr 2026
- First submitted
- 2 May 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor-Based Dual Antiplatelet Therapy in Coronary Artery Bypass Grafting: A Randomized Clinical Trial on Graft Patency
- ClinicalTrials.gov ID
- NCT06981390
- Acronym / sponsor ID
- JDEYXWK2025146
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Saphenous Vein, Dual Antiplatelet Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kexiang Liu, MDUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coronary artery bypass grafting (CABG) is a widely used revascularization strategy for patients with complex coronary artery disease. However, the long-term patency of saphenous vein grafts (SVGs) remains a significant clinical concern, with graft occlusion being a major contributor to recurrent ischemic events. Dual antiplatelet therapy (DAPT), consisting of Ticagrelor and Aspirin, is commonly used to prevent thrombosis and improve graft patency, yet the optimal duration of DAPT post-CABG remains unclear. This randomized, double-blind, controlled trial aims to assess the effects of different DAPT durations on SVG patency and clinical outcomes in CABG patients. A total of 300 patients undergoing isolated CABG with at least one SVG will be enrolled and randomly assigned (1:1:1) 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 of the study is SVG patency at 12 months, assessed via coronary CT angiography, defined as FitzGibbon Grade A (≤50% stenosis). Secondary outcomes include bleeding events , major adverse cardiovascular and cerebrovascular events (MACCE), and all-cause mortality. Patients will be followed at 3, 6, and 12 months postoperatively, undergoing clinical assessments, laboratory tests, and imaging evaluations to monitor graft patency, bleeding complications, and cardiovascular and cerebrovascular events. The study will provide critical data to determine the optimal duration of DAPT to maximize graft patency while minimizing bleeding risks, ultimately guiding personalized antiplatelet strategies in CABG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-Month DAPT Group | Active comparator | Drug: Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy |
| 6-Month DAPT Group | Active comparator | Drug: Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy |
| 12-Month DAPT Group | Experimental | Drug: Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)Ticagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18-80 of age.
- Patients undergo planned CABG for the first time with ≥1 SVGs
- Patients with written informed consent.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy)Also: 3-Month DAPTTicagrelor (90 mg BID) + Aspirin (100 mg QD) for 3 months, followed by aspirin monotherapy | Drug | 3-Month DAPT Group |
| Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy)Also: 6-Month DAPTTicagrelor (90 mg BID) + Aspirin (100 mg QD) for 6 months, followed by aspirin monotherapy | Drug | 6-Month DAPT Group |
| Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy)Also: 12-Month DAPTTicagrelor (90 mg BID) + Aspirin (100 mg QD) for 12 months, followed by aspirin monotherapy | Drug | 12-Month DAPT Group |
Primary outcome
Saphenous Vein Graft (SVG) Patency at 12 Months
Time frame: 12 months post-CABG
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).
3 secondary outcomes
Bleeding Events
Time frame: Up to 12 months post-CABG
MACCE episodes
Time frame: Within 1-year after CABG
All-Cause Mortality
Time frame: Up to 12 months post-CABG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
kexiang liu study director
Second Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ticagrelor + Aspirin for 3 Months (followed by aspirin monotherapy), Ticagrelor + Aspirin for 6 Months (followed by aspirin monotherapy) and Ticagrelor + Aspirin for 12 Months (followed by aspirin monotherapy) in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Kexiang Liu, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kexiang liu (17390920328, kxliu64@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saphenous Vein Graft (SVG) Patency at 12 Months (time frame: 12 months post-CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.