De-escalation of antiplatelet therapy after heart bypass surgery

Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting in Patients Without Acute Coronary Syndrome

This study is testing if a shorter course of antiplatelet medication after heart bypass surgery can keep patients safe and healthy just as well as the standard longer treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 2300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (other gov)
• Drugs / interventions: methotrexate
• Locations: 1 site (Beijing)
• Trial ID: NCT05380063 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of a de-escalated dual antiplatelet therapy (De-DAPT) compared to standard dual antiplatelet therapy (DAPT) in patients undergoing coronary artery bypass grafting (CABG). It is a multicenter, randomized, double-blind, non-inferiority trial involving at least 2,300 patients across 10 centers. Participants will be assigned to either the DAPT group, receiving ticagrelor and aspirin for 12 months, or the De-DAPT group, receiving the same for the first 3 months followed by aspirin and placebo for the remaining 9 months. The primary focus is to assess graft occlusion rates and bleeding events between the two groups.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-80 undergoing their first planned CABG with at least one saphenous vein graft.

Not a fit: Patients undergoing emergency CABG or those with specific contraindications to antiplatelet therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce bleeding complications while maintaining effective graft patency in CABG patients.

How similar studies have performed: Previous studies have explored dual antiplatelet therapy, but this specific de-escalation approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion criteria

1. Patients 18-80 of age. 2. Patients undergo planned CABG for the first time with ≥1 SVGs 3. Patients with written informed consent. Exclusion criteria

1. Concomitant valve (excluding aortic bioprosthesis), aorta, or rhythm surgery during the same session.
2. Patients undergo emergency CABG.
3. Patients with single coronary artery disease.
4. Patients with cardiogenic shock and hemodynamic instability.
5. Patients with sick sinus syndrome, 2nd or 3rd atrioventricular block.
6. Patients with contraindications for coronary computed tomography angiography or coronary angiography (eg. contrast allergy).
7. Use of other antiplatelet drugs than aspirin or ticagrelor (clopidogrel, prasugrel, etc) and unable to discontinue this medication after CABG, in the treating physician's or the investigator's opinion.
8. Patients who take oral anticoagulants before CABG and have to use anticoagulants after surgery.
9. Contraindication for the use of ticagrelor or aspirin (ie. history of bleeding diathesis within 3 months prior presentation, severe gastrointestinal bleeding within 1year prior presentation, peptic ulcer without gastrointestinal bleeding in past 3 years or history of intracranial hemorrhage, allergy, severe gastrointestinal reaction caused by aspirin).
10. Placement of a drug-eluting stent in a coronary or cerebral artery within 6 months of CABG or placement of a bare-metal stent in a coronary or cerebral artery within 1 month of CABG
11. Thrombocytopenia before CABG (\< 100 x 109/L).
12. patients with severe renal function impairment requiring dialysis or active liver disease, including patients with unexplained persistent elevated transaminase or any transaminase more than 3 times the normal limit.
13. Use of strong inhibitors of CYP3A4
14. Patients who have to use methotrexate and ibuprofen.
15. Patients with active malignant tumors with increase in bleeding risk in the investigator's opinion
16. Pregnant patients, patients who have given birth within the past 90 days, or who are breastfeeding.
17. Premenopausal women who do not take adequate contraception. Adequate contraception refers to the adoption of at least two reliable methods of contraception, one of which must be a barrier method of contraception.
18. CABG volume of the surgeon less than 50.

Where this trial is running

Beijing

• Fuwai Hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Shengshou Hu, MD — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Xin Yuan, PhD

Conditions: Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Infarction, Myocardial Ischemia, Angina Pectoris, Ticagrelor