A Multi-center RCT Trial on Prognosis of Patients With Anticoagulation and DAPT Therapy After LAAC

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04135677

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is to assess the different dosage of rivaroxaban application versus dual antiplatelet therapy for prevention of device-related-thrombus in patients undergoing left atrial appendage closure using the WATCHMAN device.

Condition or Disease	Intervention/Treatment	Phase
Left Atrial Appendage Thrombosis Thrombi Stroke	Drug: Rivaroxaban Drug: Rivaroxaban Drug: DAPT	Phase 4

Detailed Description

Transcatheter left atrial appendage occlusion(LAAO) has emerged as an effective alternative for preventing thromboembolic events in patients with nonvalvular atrial fibrillation. The contemporary strategy for post-implantation antithrombotic medication therapy derived from several initial industrialized authoritative researches, demonstrated as 45days for anticoagulation and prolonged DOAC for 6 months. In spite of the increasing experience of operators and arrival of new technologies, the rates of DRT still maintained. Therefore, whether altered medication therapy post-implantation attracted overwide attention. Nowadays, new oral anticoagulation such as rivaroxaban, dabigatran has evolved empirically and successively has been applied for days-weeks anticoagulation therapy following LAAO ,yet, the specific recommended dosage remained unclear.

Therefore, the objective of the study is to compare the effects of different dosage of rivaroxaban for short-term(3months) anticoagulation therapy versus DAPT on the prevention of device thrombusis following transcatheter LAAO.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Multi-center Randomized Controlled Study of High/Low-dosage Rivaroxaban Compared With DAPT After Left Atrial Appendage Occulsion in Patients With Non-valvular Atrial Fibrillation（ESCORT-AF Study）

Anticipated Study Start Date :

Nov 30, 2019

Anticipated Primary Completion Date :

May 30, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: low-dosage group rivaroxaban 10mg qd for for 3 months and continued DAPT for 6 months.	Drug: Rivaroxaban Drug: Rivaroxaban 10mg Duration of treatment: 3 months(3months for DAPT afterwards)
Active Comparator: high-dosage group rivaroxaban 20mg qd for for 3 months and continued DAPT for 6 months.	Drug: Rivaroxaban Drug: Rivaroxaban 20mg Duration of treatment: 3 months(3months for DAPT afterwards
Active Comparator: DAPT group asprin 100mg qd together clopidogrel 75mg for 6 months	Drug: DAPT Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:6 months

Arm

Intervention/Treatment

Active Comparator: low-dosage group

rivaroxaban 10mg qd for for 3 months and continued DAPT for 6 months.

Drug: Rivaroxaban

Drug: Rivaroxaban 10mg Duration of treatment: 3 months(3months for DAPT afterwards)

Active Comparator: high-dosage group

rivaroxaban 20mg qd for for 3 months and continued DAPT for 6 months.

Drug: Rivaroxaban

Drug: Rivaroxaban 20mg Duration of treatment: 3 months(3months for DAPT afterwards

Active Comparator: DAPT group

asprin 100mg qd together clopidogrel 75mg for 6 months

Drug: DAPT

Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:6 months

Outcome Measures

Primary Outcome Measures

Device thrombosis evaluated by TEE [3 months after LAAC]

Secondary Outcome Measures

Device thrombosis evaluated by TEE [6,12-month follow-up]
Ischemic events(TIA,stroke) [3,6,12-month follow-up]
Bleeding events [3,6,12-month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Successful transcatheter LAAC with any approved device
Age18-75 years old
Weight≥50kg

Exclusion Criteria:

Absolute contraindications for anticoagulation therapy
Prior intracranial hemorrhage
Contraindications for TEE
Severe pericardial effusion within the first 24 hrs following LAAC
Major/life-threatening bleeding within the first 24 hrs following LAAC
Female subjects of childbearing potential without using highly effective methods of contraception
Serious renal insufficiency(CRCL<30ml/min)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT04135677

Other Study ID Numbers:

DRXCZ

First Posted:

Oct 23, 2019

Last Update Posted:

Oct 23, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombosis

Rivaroxaban

Study Results

No Results Posted as of Oct 23, 2019