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Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting (TOP-CABG)

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
De-escalated Dual Antiplatelet Therapy
Dual Antiplatelet Therapy
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass Grafting, Ticagrelor, Aspirin, Dual Antiplatelet Therapy, De-escalated Dual Antiplatelet Therapy, Great Saphenous Vein, Bleeding

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dual Antiplatelet Therapy (DAPT)

De-escalated Dual Antiplatelet Therapy (De-DAPT)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SVG Failure
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
Graft stenosis and occlusion
Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion
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

Full Information

First Posted
May 13, 2022
Last Updated
December 13, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05380063
Brief Title
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting
Acronym
TOP-CABG
Official Title
Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting in Patients Without Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Bypass Grafting, Dual Antiplatelet Therapy, Bleeding, Myocardial Infarction, Myocardial Ischemia, Angina Pectoris
Keywords
Coronary Artery Bypass Grafting, Ticagrelor, Aspirin, Dual Antiplatelet Therapy, De-escalated Dual Antiplatelet Therapy, Great Saphenous Vein, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual Antiplatelet Therapy (DAPT)
Arm Type
Active Comparator
Arm Description
DAPT with ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year after CABG.
Arm Title
De-escalated Dual Antiplatelet Therapy (De-DAPT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
De-escalated Dual Antiplatelet Therapy
Other Intervention Name(s)
De-escalation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dual Antiplatelet Therapy
Intervention Description
Ticagrelor (90mg twice daily) + aspirin (100 mg once daily) for 1 year post CABG.
Primary Outcome Measure Information:
Title
100% great saphenous vein (SVG) grafts occlusions
Description
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
Title
Bleeding events
Description
Bleeding events as defined by the BARC classification ≥ 2 at 1 year after CABG.
Time Frame
During 0-day to 1-year after CABG
Secondary Outcome Measure Information:
Title
SVG Failure
Description
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
Title
Graft stenosis and occlusion
Description
Significant (≥70%) venous or arterial graft stenosis and any (venous or arterial) graft occlusion
Time Frame
During 0-day to 1-year after CABG
Title
MACCE episodes
Description
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
Within 1-year after CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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 Pregnant patients, patients who have given birth within the past 90 days, or who are breastfeeding. 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. CABG volume of the surgeon less than 50.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Yuan, PhD
Phone
86-10-88322630
Email
yuanxinfuwai@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Chu, PhD
Phone
86-18810919868
Email
L51chuqing@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengshou Hu, MD
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Yuan, PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qing Chu, PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kai Chen
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Yuan, PhD
Phone
86-10-88322630
Email
yuanxinfuwai@163.com
First Name & Middle Initial & Last Name & Degree
Qing Chu, PhD
Phone
86-18810919868
Email
L51chuqing@163.com
First Name & Middle Initial & Last Name & Degree
Shengshou Hu, MD
First Name & Middle Initial & Last Name & Degree
Xin Yuan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Ticagrelor-based De-escalation of Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting

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