Minimally Invasive Coronary Artery Bypass Supported by Cangrelor

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCardiocentro Ticino

About this trial

The purpose of this study is to find out whether it is safe and practical to perform MIDCAB surgery (a minimally invasive heart bypass procedure) while patients receive a continuous cangrelor infusion during the operation. Cangrelor is a medicine that helps prevent blood clots and works quickly through a vein drip.

The study compares patients receiving cangrelor during surgery to patients who had the same surgery in the past while on aspirin, with or without cangrelor given beforehand.

Study Question: Can MIDCAB surgery be safely performed under cangrelor infusion, without increasing the risk of bleeding or other complications?

Hypothesis: Using cangrelor during MIDCAB surgery is safe and feasible, and it provides effective protection against blood clots during the procedure.

This study will help doctors understand whether intraoperative cangrelor can improve patient safety and outcomes in minimally invasive heart surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old

CABG with IMA-LAD graft in MIDCAB technique

Age ≥18 years old

CABG with IMA-LAD graft in MIDCAB technique

Disqualifiers

Administration of fibrinolytics or GP IIb/IIIa inhibitors

Previous intracranial hemorrhage

Known bleeding diathesis

Patients undergoing concomitant PCI and MIDCAB

Trial population

The study population includes adult patients scheduled for minimally invasive direct coronary artery bypass (MIDCAB) surgery at Cardiocentro Ticino Institute, Lugano, Switzerland. Patients will be selected for either prospective cangrelor-guided MIDCAB or retrospective historical control MIDCAB under aspirin therapy. The population includes individuals with multivessel coronary artery disease requiring LIMA-LAD bypass, regardless of sex or comorbidities, who meet all inclusion and no exclusion criteria. Patients with planned concomitant PCI are excluded. This population represents real-world candidates for MIDCAB surgery under antiplatelet management protocols.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Cangrelor-guided MIDCAB surgery (for the prospective cases)

    Procedure/Surgery

    Cangrelor-guided MIDCAB surgery: Patients undergo minimally invasive direct coronary artery bypass (MIDCAB) with continuous intravenous cangrelor infusion at 0.75 μg/kg per minute. Prior oral antiplatelet therapy is discontinued, and platelet function is monitored daily using Multiplate® testing. Cangrelor infusion is started when platelet aggregation reaches predefined thresholds and continued throughout surgery until it is safe to restart oral antiplatelet therapy.

  • Aspirin MIDCAB surgery (for the historical controls)

    Procedure/Surgery

    Aspirin MIDCAB surgery: Historical control patients underwent MIDCAB under aspirin therapy, with or without prior bridging with cangrelor. Perioperative management follows standard care, including anticoagulation with unfractionated heparin during surgery and routine monitoring of laboratory and clinical outcomes.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cangrelor MIDCAB Group (Prospective Cases)1 intervention
Group B: Aspirin MIDCAB Group (Historical Controls)1 intervention

Trial outcomes

Primary outcomes

1

Excessive CABG-related bleeding during and after MIDCAB surgery

Excessive bleeding is defined as the occurrence of at least one of the following: (1) bleeding requiring surgical re-exploration, (2) 24-hour chest tube output greater than 1 liter, or (3) transfusion of more than 4 units of packed red blood cells. This measure assesses the safety of cangrelor-guided MIDCAB compared with historical aspirin-treated controls.

Time frame
From the start of surgery through 24 hours postoperatively

Secondary outcomes

1

In-hospital MACCE

Occurrence of all-cause death, myocardial infarction, stroke, or urgent revascularization; each component assessed separately.

Time frame
From surgery through hospital discharge, an average of 8 days
2

Probable or Defined Stent Thrombosis

Incidence of stent thrombosis confirmed by angiography or clinical criteria (probable or definite).

Time frame
From surgery through hospital discharge, an average of 8 days
3

Cardiac Injury (High-Sensitivity Troponin)

Daily measurement of high-sensitivity troponin before and after MIDCAB to assess perioperative myocardial injury.

Time frame
Preoperative baseline until hospital discharge, an average of 10 days
4

Chest Tube Output

Volume of postoperative chest drainage measured at 6, 12, 24, and 48 hours after surgery.

Time frame
6, 12, 24, and 48 hours postoperatively

Other outcomes

1

Serious Adverse Events and Adverse Drug Reactions

Any untoward medical occurrence during the study that meets criteria for a Serious Adverse Event (death, life-threatening event, hospitalization, permanent impairment, or medical/surgical intervention to prevent permanent damage) or an Adverse Drug Reaction related to cangrelor infusion. Expected ADRs include bleeding, cardiac tamponade, acute kidney injury, hypersensitivity, dyspnea, or fructose intolerance. Other adverse events are monitored and recorded per protocol.

Time frame
From study inclusion through hospital discharge or resolution of ongoing events, an average of 10 days

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