NCT05380063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

August 27, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

May 13, 2022

Last Update Submit

August 25, 2025

Conditions

Coronary Artery DiseaseCoronary Artery Bypass GraftingDual Antiplatelet TherapyBleedingMyocardial InfarctionMyocardial IschemiaAngina Pectoris

Keywords

Coronary Artery Bypass GraftingTicagrelorAspirinDual Antiplatelet TherapyDe-escalated Dual Antiplatelet TherapyGreat Saphenous VeinBleeding

Outcome Measures

Primary Outcomes (2)

  • 100% great saphenous vein (SVG) grafts occlusions

    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

    During 0-day to 1-year after CABG

  • Bleeding events

    Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.

    During 0-day to 1-year after CABG

Secondary Outcomes (3)

  • SVG Failure

    During 0-day to 1-year after CABG

  • Graft stenosis and occlusion

    During 0-day to 1-year after CABG

  • MACCE episodes

    Within 1-year after CABG

Other Outcomes (17)

  • Subgroup analysis 1 for primary outcome

    1 year

  • Subgroup analysis 2 for primary outcome

    1 year

  • Subgroup analysis 3 for primary outcome

    1 year

  • +14 more other outcomes

Study Arms (2)

Dual Antiplatelet Therapy (DAPT)

ACTIVE COMPARATOR

DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.

Drug: Dual Antiplatelet Therapy

De-escalated Dual Antiplatelet Therapy (De-DAPT)

EXPERIMENTAL

De-DAPT referred to ticagrelor (90mg twice daily) + aspirin (100 mg once daily) during first 3 months post CABG, then switch to aspirin (100 mg once daily) + placebo (twice daily) for 9 months.

Drug: De-escalated Dual Antiplatelet Therapy

Interventions

De-escalated Dual Antiplatelet TherapyDRUG

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.

Also known as: De-escalation
De-escalated Dual Antiplatelet Therapy (De-DAPT)
Dual Antiplatelet TherapyDRUG

Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.

Dual Antiplatelet Therapy (DAPT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Concomitant valve (excluding aortic bioprosthesis), aorta, or rhythm surgery during the same session.
  • Patients undergo emergency CABG.
  • Patients with single coronary artery disease.
  • Patients with cardiogenic shock and hemodynamic instability.
  • Patients with sick sinus syndrome, 2nd or 3rd atrioventricular block.
  • Patients with contraindications for coronary computed tomography angiography or coronary angiography (eg. contrast allergy).
  • 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.
  • Patients who take oral anticoagulants before CABG and have to use anticoagulants after surgery.
  • 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).
  • 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
  • Thrombocytopenia before CABG (\< 100 x 109/L).
  • 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.
  • Use of strong inhibitors of CYP3A4
  • Patients who have to use methotrexate and ibuprofen.
  • Patients with active malignant tumors with increase in bleeding risk in the investigator's opinion
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, China

Location

Related Publications (1)

  • Yuan X, Chu Q, Chen K, Wang Y, Zhang L, Zheng Y, Hu S. Multicentre, randomised, double-blind, parallel controlled trial to investigate timing of platelet inhibition after coronary artery bypass grafting: TOP-CABG trial study. BMJ Open. 2023 Jun 29;13(6):e070823. doi: 10.1136/bmjopen-2022-070823.

    PMID: 37385747DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHemorrhageMyocardial InfarctionMyocardial IschemiaAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfarctionIschemiaNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Shengshou Hu, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

  • Xin Yuan, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

  • Qing Chu, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY DIRECTOR

  • Kai Chen

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

February 14, 2023

Primary Completion

July 8, 2025

Study Completion

July 10, 2025

Last Updated

August 27, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)