NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1031190030

Registered date:27/05/2019

Comparing change in coagulation system during catheter invasion between IIa inhibitors versus Xa inhibitors.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAtrial fibrillation
Date of first enrollment15/08/2019
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)Direct thrombin inhibitors group: Dabigatran capsule 2 times a day. (110mg capsule for low-dose patients, two 75mg capsules for others) Direct Xa inhibitors group: Apixaban tablet 2 times a day. (2.5mg tablet for low-dose patients, 5.0mg tablet for others)

Outcome(s)

Primary OutcomeChange amount of prothrombin fragment 1+2 (F1+2) before and after blood vessel puncture during catheter ablation
Secondary OutcomeValue and rate of change of prothrombin fragment 1+2 (F1+2) before and after blood vessel puncture during catheter ablation Value, change amount and rate of change of antithrombin, protein S and protein C before and after blood vessel puncture during catheter ablation

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum<= 79age old
GenderBoth
Include criteriaAge >= 40 and < 80 years Atrial fibrillation and indication for treatment with anticoagulant Planning to undergo catheter ablation of atrial fibrillation
Exclude criteriaBleeding in intracranial, retroperitoneal or other important organs High bleeding risk Liver disease with child pugh score B/C and abnormal blood clot eCCr < 50 mL/min by Cockcroft-Gault's equation or dialysis Heart failure (NYHA classification >=3, left ventricular ejection fraction <= 35% or hospitalization due to heart failure within 1 year) Nutritional disorders Cancer

Related Information

Contact

Public contact
Name Yasuhiro Ikami
Address 1-757 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan Niigata Japan 951-8510
Telephone +81-25-227-2185
E-mail yasu.ik@gmail.com
Affiliation Niigata University Graduate School of Medical and Dental Sciences
Scientific contact
Name Daisuke Izumi
Address 1-757 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan Niigata Japan 951-8510
Telephone +81-25-227-2185
E-mail dizumi@med.niigata-u.ac.jp
Affiliation Niigata University Graduate School of Medical and Dental Sciences