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

Beijing Anzhen Hospital950 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

950

Conditions

Coronary Artery Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Major adverse cardiovascular events

A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke

Time frame: Perioperative period

Secondary Outcomes

TIMI major or minor bleeding

A composite of major or minor bleeding events as defined by the TIMI bleeding criteria

Time frame: Perioperative period

Net adverse clinical events

A composite of major adverse cardiovascular events and TIMI major or minor bleeding

Time frame: Perioperative period

Net adverse clinical events

A composite of major adverse cardiovascular events and TIMI major or minor bleeding

Time frame: 30 days after surgery

Central Contacts

Xiaoli Liu, PhD, MD

CONTACT

8613581633895 liuxl9881@163.com

Data from ClinicalTrials.gov

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