A Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation

NCT03792152 | Unknown DMC

• 1 other identifier: REVIEW-AF
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.

Conditions

Atrial Fibrillation; Left Atrial Appendage Thrombosis; Rivaroxaban

Keywords

Atrial Fibrillation; Left Atrial Appendage Thrombosis; rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks

  Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy.

  6 weeks

Secondary Outcomes (4)

• Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks

  12 weeks

• Size change of left atrial appendage or left atrium thrombus

  12 weeks

• Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage.

  12 weeks

• Number of transient ischemic attacks (TIA) and strokes

  12 weeks

Study Arms (2)

rivaroxaban

EXPERIMENTAL

After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd(15mg If creatinine clearance is between 30-49 ml/min ).

Drug: Rivaroxaban

Warfarin

ACTIVE COMPARATOR

After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.

Drug: Warfarin

Interventions

Rivaroxaban DRUG

After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd (15mg If creatinine clearance is between 30-49 ml/min).

rivaroxaban

Warfarin DRUG

After the diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin (4000iu q12h) and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.

Warfarin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Get informed consent from the patient or family.
• Non-valvular atrial fibrillation / atrial flutter.
• The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus).
• Age at 18-80 years old.
• CrCL≥ 30 mL/min (Cockcroft-Gault).
• AST/ALT is less than 2 times the upper limit of normal.
• Women of childbearing age need contraception.

You may not qualify if:

• Pregnant or lactating woman.
• Can't understand or follow the research plan.
• Patients under 18 or over 80 years old.
• Low weight (\< 40 kg).
• Previously found LAA thrombus and have taken anticoagulant drugs.
• Patients with contraindications for anticoagulation.
• Patients who need to use antiplatelet drugs simultaneously within 6-12 months after ACS or PCI.
• A history of cerebral hemorrhage.
• Patients with active bleeding.
• Severe gastritis, gastroesophageal reflux patients.
• Combination of P-glycoprotein inhibitors and other drugs in the presence of NOAC contraindications.
• Patient with tumor. 14.Planned surgery within 3 months. 15.Other investigators believe that patients are not suitable for enrollment.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Related Publications (1)

• Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TRA) and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2016 Aug;178:126-34. doi: 10.1016/j.ahj.2016.05.007. Epub 2016 May 17.

  PMID: 27502860 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

ZHIYU LING, MD

CONTACT

+8613512362075; lingzy1977@163.com

YANPING XU

CONTACT

+86-023-63693079

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After receiving the informed consent form patient, The heads of the centers randomly extracted the envelopes and patients are included in the study based on random envelope grouping results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: two groups, group one is for Rivaroxaban 20mg qd (15mg qd If creatinine clearance is between 30-49ml/min), group two is for warfarin, keep the INR between 2-3.

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: June 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: December 30, 2022
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share