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

Capital Medical University

Status: Unknown

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04675801

SAFE

Details and patient eligibility

About

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.

Enrollment: 950 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

950 participants in 2 patient groups

Bridging therapy with LMWH (n=475)

Description:

Bridging therapy with LMWH was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery

Bridging therapy with tirofiban (n=475)

Description:

Bridging therapy with tirofiban was performed after discontinuation of oral antiplatelet agents prior to non-cardiac surgery