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SAPT Versus DAPT in Incomplete Revascularization After CABG

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCampus Bio-Medico University

About this trial

The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).

Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)

incomplete myocardial revascularization, defined by anatomic or functional criteria

obtained informed consent

Disqualifiers

acute coronary syndrome < 12 months from surgery

dual antiplatelet therapy at hospital admission

planned procedure to complete myocardial revascularization (e.g. hybrid approach)

intolerance / unable to take acetylsalicylic acid or ticagrelor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ticagrelor

    Drug

    90 mg bis in die

  • acetylsalicylic acid

    Drug

    100 mg die

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: DAPTExperimental treatment 2 interventions
Group B: SAPTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cardiac-related mortality

Time frame
5 years

Secondary outcomes

1

Mortality

Overall mortality and non-cardiac-related mortality

Time frame
5 years
2

Major adverse cardiac and cerebrovascular events (MACCEs)

cardiac-related mortality, myocardial infarction, repeated vessel revascularization, hospitalization for heart failure, major arrhythmias, stroke

Time frame
5 years
3

Major adverse hemorrhagic events (MAHEs)

stroke, gastrointestinal bleeding, life-threatening bleeding

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Campus Bio-Medico University

Lead sponsor

Source ClinicalTrials.gov
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