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Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

ConditionsAnticoagulationCoronary Endarterectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the final option for achieving complete revascularization in diffuse coronary artery disease patients. Since the exposure of subendothelial tissue to the blood flow after CE, the coagulation cascade can be activated, resulting in the increased risk of graft failure. Therefore, anticoagulation with warfarin in this group of patients might be beneficial. However, evidence is limited. This study aims to compare the clinical outcomes between dual antiplatelet therapy with or without warfarin after CE+CABG.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with diffuse coronary artery disease undergoing CE+CABG during the study period.

No contraindications for both dual antiplatelet therapy and anticoagulation therapy with warfarin.

Must be able to swallow tablets after the surgery.

Disqualifiers

Patients with high bleeding risk (HAS-BLED ≥ 3);

Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time;

Emergency surgery;

Serum creatinine >130μmol/L, or significant liver dysfunction (elevated ALT and/or AST);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Warfarin

    Drug

    dual antiplatelet therapy combined with warfarin

  • DAPT

    Drug

    Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)

  • CE+CABG

    Other intervention

    Coronary endarterectomy combined with coronary artery bypass grafting

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: DAPTOther 2 interventions
Group B: DAPT+warfarinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Rate of coronary endarterectomy-targeted graft patency.

Defined as less than 50% stenosis of the coronary endarterectomy target and coronary endarterectomy-targeted graft evaluated through either of coronary computed tomography angiography or coronary angiography.

Time frame
6 months postoperatively

Secondary outcomes

1

Number of patients suffering from major adverse cardiovascular and cerebrovascular events

Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

Time frame
During 6-month follow-up
2

Bleeding events

The Bleeding Academic Research Consortium (BARC) scale type 2\~5 \[see in reference\].

Time frame
during 6-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov
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