SAfety and EFficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery

• Conditions: Coronary Artery Disease

• Registration Number: NCT04675801
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

Patients with coronary artery disease, especially after PCI, require long-term oral antiplatelet therapy. However, this patient population may inevitably require non-cardiac surgery for a variety of conditions. In order to avoid the occurrence of bleeding events, oral antiplatelet agents are usually discontinued before non-cardiac surgery in patients with coronary artery disease, which may increase the incidence of ischemic events. Therefore, it is important to provide patients with the optimal perioperative antithrombotic treatment to balance the risk of bleeding and ischemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Study Start: 2021-03-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-11
• Primary Completion: 2023-04
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

1. Aged 18 years or over
2. Established coronary artery disease being treated with oral antiplatelet therapy
3. Non-cardiac surgery is planned and bridging antithrombotic therapy is considered necessary
4. Agree to participate in the study and provide written informed consent

Exclusion Criteria

1. According to the consensus of Chinese experts on antiplatelet therapy in 2013, the surgical bleeding risk is low or extremely low
2. Requiring emergency non-cardiac surgery within 24 hours after admission
3. Currently being bleeding
4. Moderate or severe ischemic stroke or spontaneous intracranial hemorrhage in the past 6 months or traumatic intracranial hemorrhage in the past 1 year
5. Intracranial diseases or hemorrhagic diathesis
6. Contraindications for LMWH or GP IIb/IIIa receptor antagonists

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	Perioperative period	A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke

Secondary Outcome Measures

Name	Time	Method
TIMI major or minor bleeding	Perioperative period	A composite of major or minor bleeding events as defined by the TIMI bleeding criteria
Net adverse clinical events	30 days after surgery	A composite of major adverse cardiovascular events and TIMI major or minor bleeding

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China