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

NCT04675801 | Unknown DMC

• 1 other identifier: SAFE
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

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

  Perioperative period

Secondary Outcomes (3)

• TIMI major or minor bleeding

  Perioperative period

• Net adverse clinical events

  Perioperative period

• Net adverse clinical events

  30 days after surgery

Study Arms (2)

Bridging therapy with LMWH (n=475)

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

Bridging therapy with tirofiban (n=475)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Coronary artery disease patients treated with oral antiplatelet therapy are planned to undergo non-cardiac surgery with high or extremely high surgical bleeding risk

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Xiaoli Liu, PhD, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoli Liu, PhD, MD

CONTACT

8613581633895; liuxl9881@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: March 2, 2021
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)