NCT07514962

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
17mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
May 2024Jan 2028

Study Start

First participant enrolled

May 12, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

March 25, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Minimally Invasive Direct Coronary Artery BypassMIDCAB SurgeryCoronary Artery DiseaseCangrelorPerioperative Antiplatelet TherapyPlatelet Function MonitoringBridging TherapyCardiac SurgeryIntraoperative Antiplatelet ManagementBleeding Risk

Outcome Measures

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.

    From the start of surgery through 24 hours postoperatively

Secondary Outcomes (12)

  • In-hospital MACCE

    From surgery through hospital discharge, an average of 8 days

  • Probable or Defined Stent Thrombosis

    From surgery through hospital discharge, an average of 8 days

  • Cardiac Injury (High-Sensitivity Troponin)

    Preoperative baseline until hospital discharge, an average of 10 days

  • Chest Tube Output

    6, 12, 24, and 48 hours postoperatively

  • Blood Transfusion Requirements and Nadir Hemoglobin

    From surgery through hospital discharge, an average of 8 days

  • +7 more secondary outcomes

Other Outcomes (1)

  • Serious Adverse Events and Adverse Drug Reactions

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

Study Arms (2)

Cangrelor MIDCAB Group (Prospective Cases)

Patients prospectively enrolled to undergo MIDCAB surgery while receiving continuous cangrelor infusion at 0.75 μg/kg per minute. All prior oral antiplatelet therapy is discontinued, and platelet function is monitored daily with Multiplate® testing. Data collected include perioperative safety, bleeding outcomes, laboratory values, and clinical events.

Procedure: Cangrelor-guided MIDCAB surgery (for the prospective cases)

Aspirin MIDCAB Group (Historical Controls)

Retrospective patients who previously underwent MIDCAB surgery under aspirin therapy, with or without prior bridging with cangrelor. Relevant perioperative and clinical data are extracted from the institutional database for comparison with the prospective cases.

Procedure: Aspirin MIDCAB surgery (for the historical controls)

Interventions

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.

Cangrelor MIDCAB Group (Prospective Cases)

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.

Aspirin MIDCAB Group (Historical Controls)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Age ≥18 years old
  • CABG with IMA-LAD graft in MIDCAB technique
  • Age ≥18 years old
  • CABG with IMA-LAD graft in MIDCAB technique
  • Signed informed consent

You may not qualify if:

  • Administration of fibrinolytics or GP IIb/IIIa inhibitors
  • Previous intracranial hemorrhage
  • Known bleeding diathesis
  • Patients undergoing concomitant PCI and MIDCAB
  • Severe renal or liver disease
  • Pregnancy or breast feeding
  • Unconsciousness
  • Known hypersensitivity to study drug (cangrelor)
  • Recent administration of fibrinolytics or GP IIb/IIIa inhibitors
  • Previous intracranial hemorrhage
  • Known bleeding diathesis
  • Patients undergoing concomitant PCI and MIDCAB
  • Severe renal or liver disease
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Cardiocentro Ticino

Lugano, Ch/ti, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Marco Valgimigli, Prof. Dr. Med.

    Cardiocentro Ticino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Valgimigli, Prof Dr Med

CONTACT

Servizio di Ricerca Cardiovascolare Cardiocentro

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Chief Prof. Dr. Med

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 7, 2026

Study Start

May 12, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations