Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation

NCT ID: NCT03821883

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2024-12-01

Brief Summary

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO).

Patients diagnosed with atrial fibrillation and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Detailed Description

The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin since the sixth month after LAAO.

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 90 years and have undergone LAAO will be enrolled in this study. Randomization will be performed at 6 months post-implant. The randomization program electronically assigns the patient 1:1 to either the Aspirin group or the control group. Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day). The control group receives placebo. After the randomization, subjects of both groups will have follow-up visits at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment. For each group, 560 patients will be included, with an estimated total number of 1120 participants in this clinical study. Patients will be followed up until 24 months after the last enrollment.

The primary endpoint is a composite consisting of stroke, systemic embolism, cardiovascular or unexplainable death, acute coronary syndrome, coronary artery disease or periphery vascular disease requiring revascularization and major bleeding. The secondary endpoints are all-cause death, device related thrombus, minor bleeding and rehospitalization due to heart failure.

Conditions

Atrial Fibrillation; Stroke; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aspirin group

Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).

Group Type: EXPERIMENTAL

Aspirin Tablet

Intervention Type: DRUG

Aspirin 100mg qd

Control group

Study patients assigned to control group will receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo qd

Interventions

Aspirin Tablet

Aspirin 100mg qd

Intervention Type: DRUG

Placebo

Placebo qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 90 years
• Paroxysmal, persistent, long-standing persistent or permanent nonvalvular AF
• Have already had a Watchman LAAO device implanted 6 months ago

Exclusion Criteria

• Long-term aspirin therapy required
• Including coronary artery disease, symptomatic carotid disease, prior myocardial infarction, strokes or systemic embolism, etc
• Contraindicated for aspirin therapy
• Including active peptic ulcer, thrombocytopenia or anemia, etc.
• Uncontrolled malignant tumor
• Abnormal liver, renal or coagulation function
• Pregnant or pregnancy is planned during the course of the investigation
• Terminal illness with life expectancy <1 year
• Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug

• Peri-device leak >5mm
• Device-related thrombus
• Other intracardiac thrombus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Gang Li, Dr.

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

Xinhua Hospital, School of Medicne, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mu Chen, Dr.

Role: CONTACT

chenmu@xinhuamed.com.cn

86 021 25077275

Facility Contacts

Yi-Gang Li, Dr.

Role: primary

liyigang@xinhuamed.com.cn

86 021 25077275

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Other Identifiers

XH-18-017

Identifier Type: -

Identifier Source: org_study_id