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

JRCT ID: jRCT1031190030

Registered date:27/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial fibrillation
• Date of first enrollment: 15/08/2019
• Target sample size: 40
• Study type: Interventional

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 Outcome: Change amount of prothrombin fragment 1+2 (F1+2) before and after blood vessel puncture during catheter ablation

Secondary Outcome

Value 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
• Gender: Both

Include criteria

Age >= 40 and < 80 years
Atrial fibrillation and indication for treatment with anticoagulant
Planning to undergo catheter ablation of atrial fibrillation

Exclude criteria

Bleeding 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

• Primary Sponsor: Izumi Daisuke
• Secondary Sponsor: Ikami Yasuhiro,Niigata University Medical and Dental Hospital