Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO

NCT04135677 | Unknown Phase 4 DMC

• 1 other identifier: DRXCZ
• Study Type: interventional
• Target: 826
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using the LAMBRE device.

Conditions

Left Atrial Appendage Thrombosis; Thrombi; Stroke

Outcome Measures

Primary Outcomes (2)

• Primacy efficacy endpoint

  Number of participants with major adverse events(all-cause death, stroke/TIA, systematic embolism)

  24 weeks after LAAC

• Primacy safety endpoint

  Number of participants with bleeding events(major or life-threatening)

  24 weeks after LAAC

Secondary Outcomes (6)

• Device-related thrombosis

  at 12-,24-week follow-up

• Stroke

  at 12,24-week follow-up

• Bleeding

  at 12-,24-week follow-up

• Death

  at 12-,24-week follow-up

• Re-hospitalization

  at 12-,24-week follow-up

Study Arms (2)

DAPT group

ACTIVE COMPARATOR

asprin 100mg qd together clopidogrel 75mg for 24 weeks

Drug: DAPT

Anticoagulation group

EXPERIMENTAL

rivaroxaban 20mg qd for for 12 weeks and continued DAPT(asprin 100mg qd together clopidogrel 75mg) for 24 weeks

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Drug: Rivaroxaban 20mg Duration of treatment: 12 weeks(12 weeks for DAPT afterwards)

Also known as: new oral anticoagulation

Anticoagulation group

DAPT DRUG

Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:24 weeks

Also known as: dual antiplatelet therapy

DAPT group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography;
• Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants);
• Age18-85 years old;
• Life expectancy≥1 year;
• Written informed consent obtained;

You may not qualify if:

• Prior history of cardiac surgery or with need for intervention in limited intervals;
• Intolerant of TEE or with clinical contraindications for TEE
• Detection of LAA/LA thrombus prior to the procedure;
• Anteroposterior diameter of LAA≥60mm according to TTE
• Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L;
• Patients with hepatic disease that is associated with abnormal blood coagulation(cirrhosis: Child Pugh B an C);
• PLT ≤ 50\*10\^9/L;
• LVEF≤35% and/or NYHA≥IV；
• Allergies or contraindications to antiplatelet or anticoagulation therapy;
• At high risk of major bleedin(such as gastrointestinal ulcer at present or recently, malignant tumor with high risk of hemorrhage, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, angioaneurysms or major intraspinal or intracerebral vascular malformations, et al)
• Patients with requirement for anticoagulation therapy due to other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.);
• Occurrence of severe pericardial tamponade, major hemorrhage and other life-threatening complications after left atrial appendage closure;
• Combined with other basic complications necessary to take drugs that may affect the effect of anticoagulation and antithrombotic regimen in this study(such as pyrrole antifungal agent, human acquired immunodeficiency virus (HIV) protease inhibitor, anti arrhythmia drug dronedarone, powerful cytochrome enzyme CYP3A4 inducer including rifampicin, phenytoin sodium, carbamazepine, phenobarbital, and other anticoagulants).
• Enrolled in other clinical studies in progress;
• Researches think that the patient is not suitable to participate in this study.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan Univerisity

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Thrombosis; Stroke

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• JUNBO GE, PHD

  Fudan University

  STUDY CHAIR

Central Study Contacts

XIAOCHUN ZHANG, DR

CONTACT

15002121366; 514864787@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: November 11, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 30, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)