Fuwai Hospital
Beijing, China
NCT Number: NCT05380063
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting trial (TOP-CABG trial) is a multicenter, randomized, double-blind, non-inferiority, parallel controlled trial. The aim of TOP-CABG is to investigate whether de-escalated dual antiplatelet therapy (De-DAPT) is non-inferior to dual antiplatelet therapy (DAPT) in efficacy on inhibiting great saphenous vein (SVG) graft occlusion and is superior in reducing bleeding events in patients accepting coronary artery bypassing grafting.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beijing, China
After informed consent, at least 10 centers and 2,300 eligible admissions will be recruited. Eligible patients would be randomized (1:1) in double-blind manner (patients and treating physicians) to dual antiplatelet therapy (DAPT) group (ticagrelor 90mg bid and aspirin 100 mg qd for 12 month) and de-escalated DAPT (De-DAPT) group (90mg bid and aspirin 100 mg qd for first 3 months, and then aspirin 100 mg qd and placebo for 9 months).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ticagrelor (90mg twice daily) + aspirin (100 mg once daily) during first 3 months post CABG, then switching to aspirin (100 mg once daily) + placebo (twice daily) for 9 months.
Other names: De-escalation
Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.
Time frame: During 0-day to 1-year after CABG
100% SVG During 0-day to 1-year after CABG (Fitz Gibbon grade O). SVG grafts were assessed by multislice computed tomographic angiography or coronary angiography and interpreted by an independent Image Data Review Centre blinded to treatment allocation
Time frame: During 0-day to 1-year after CABG
Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.
Time frame: During 0-day to 1-year after CABG
a composite of SVG occlusion in any SVG as defined above, SVG revascularization, myocardial infarction in myocardial territory supplied by an SVG, or sudden death, as defined by the American College of Cardiology and American Heart Association and judged by an independent Clinical Endpoint Committee blinded to treatment allocation
Time frame: During 0-day to 1-year after CABG
Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion
Time frame: Within 1-year after CABG
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
Time frame: 1 year
Age (<65 years, ≥65 years)
Time frame: 1 year
Sex (male, female)
Time frame: 1 year
Body mass index (<25 kg/m2, ≥25 kg/m2)
Time frame: 1 year
Acute Coronary Syndrome (yes, no)
Time frame: 1 year
Hypertension (yes, no)
Time frame: 1 year
Diabetes (yes, no)
Time frame: 1 year
Dyslipidemia (yes, no)
Time frame: 1 year
Prior myocardial infarction (yes, no)
Time frame: 1 year
Current smoker (yes, no)
Time frame: 1 year
Left ventricular ejection fraction (<50%, ≥50%)
Time frame: 1 year
eGFR (<60/ml/min/1.75m2, ≥60/ml/min/1.75m2)
Time frame: 1 year
Statin (yes, no)
Time frame: 1 year
Beta-blocker (yes, no)
Time frame: 1 year
RASi (yes, no)
Time frame: 1 year
Off-pump (yes, no)
Time frame: 1 year
Grafts (<3 , ≥3)
Time frame: 1 year
Syntax score(≤22, 23-32 , ≥33)
China National Center for Cardiovascular Diseases
Other Gov
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting in Patients Without Acute Coronary Syndrome
Acronym: TOP-CABG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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