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

Coronary Artery Disease Clinical Trial

— SAFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675801
• Other study ID #: SAFE
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: June 2023

Study information

• Verified date: November 2021
• Source: Beijing Anzhen Hospital
• Contact: Xiaoli Liu, PhD, MD
• Phone: 8613581633895
• Email: liuxl9881[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	A composite of all-cause death, non-fatal myocardial infarction, or non-fatal stroke	Perioperative period
Secondary	TIMI major or minor bleeding	A composite of major or minor bleeding events as defined by the TIMI bleeding criteria	Perioperative period
Secondary	Net adverse clinical events	A composite of major adverse cardiovascular events and TIMI major or minor bleeding	Perioperative period
Secondary	Net adverse clinical events	A composite of major adverse cardiovascular events and TIMI major or minor bleeding	30 days after surgery