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

Safety and Efficacy of Bridging Antithrombotic Therapy During Elective Non-cardiac Surgery for Coronary Artery Disease Patients Treated With Oral Antiplatelet Agents

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04675801

Acronym

SAFE

Enrollment

950

Registered

2020-12-19

Start date

2021-03-02

Completion date

2023-06-30

Last updated

2021-11-11

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

Conditions

Coronary Artery Disease

Keywords

Bridging antithrombotic therapy, Non-cardiac surgery, coronary artery disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	Perioperative period	A composite of major adverse cardiovascular events and TIMI major or minor bleeding

Countries

China

Contacts

Primary ContactXiaoli Liu, PhD, MD

liuxl9881@163.com8613581633895

Outcome results