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A randomized controlled study comparing the perioperative efficacy and safety of fondaparinux sodium with low molecular weight heparin sodium before simple coronary artery bypass grafting in non ST-segment elevation acute coronary syndrome

A randomized controlled study comparing the perioperative efficacy and safety of fondaparinux sodium with low molecular weight heparin sodium before simple coronary artery bypass grafting in non ST-segment elevation acute coronary syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060740
Enrollment
Unknown
Registered
2022-06-09
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non ST-segment elevation acute coronary syndrome

Interventions

Group A:Subcutaneous injection of fondaparinux sodium
Group B:Subcutaneous injection of low molecular weight heparin sodium

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Patients diagnosed with ACS but not suitable for PCI or failed to attempt PCI and received simple coronary artery bypass grafting (CABG); The specific definition criteria were: coronary angiography showed that the left main artery stenosis was greater than or equal to 50% and / or three coronary artery lesions were greater than or equal to 70%, the lesions were seriously calcified, tortuous and angular, the emergency PCI treatment failed, or the complete revascularization could not be achieved, which was not suitable for PCI; 3. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency thrombolytic therapy; 2. Simultaneous CABG and valve replacement / plastic surgery, abnormal structure repair or correction, atrial fibrillation maze surgery (COX) and so on; 3. Patients who stopped fondaparinux sodium or low molecular weight heparin for more than 24 hours before operation; 4. Patients treated with fondaparinux sodium and low molecular weight heparin within 24 hours before operation; 5. Fondaparinux sodium / low molecular weight heparin and platelet glycoprotein IIb / IIIa receptor antagonist were used simultaneously before operation; 6. Body weight < 40 kg; 7. Creatinine clearance rate <= 20 mL/min; 8. Active bleeding with clinical significance before using fondaparinux sodium or low molecular weight heparin; 9. Acute bacterial endocarditis; 10. Acute myocarditis; 11. CABG is non-stop operation; 12. The perfusion mode of systemic circulation is retrograde perfusion (through femoral artery).

Design outcomes

Primary

MeasureTime frame
major cardiovascular events;

Secondary

MeasureTime frame
Composite endpoints of major cardiovascular events, heart failure, cardiogenic shock, sustained ventricular arrhythmia, or death from any cause;

Countries

China

Contacts

Public ContactYuyang Chen

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

cyy6381@163.com+86 15820284142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026