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

NCT ID: NCT04675801

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-02

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Bridging antithrombotic therapy Non-cardiac surgery coronary artery disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bridging therapy with LMWH (n=475)

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

No interventions assigned to this group

Bridging therapy with tirofiban (n=475)

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yujie Zhou

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoli Liu, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoli Liu, PhD, MD

Role: CONTACT

Phone: 8613581633895

Email: [email protected]

Facility Contacts

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Xiaoli Liu, PhD, MD

Role: primary

Xiaoteng Ma, PhD, MD

Role: backup

Other Identifiers

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SAFE

Identifier Type: -

Identifier Source: org_study_id