Back to results

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

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

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.

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

NCT ID

NCT05380063

First Posted

May 13, 2022

Last Updated

December 13, 2022

Sponsor

China National Center for Cardiovascular Diseases

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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

yuanxinfuwai@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qing Chu, PhD

Phone

86-18810919868

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

yuanxinfuwai@163.com

First Name & Middle Initial & Last Name & Degree

Qing Chu, PhD

Phone

86-18810919868

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs