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

Randomized controlled trial of direct thrombin inhibitors versus direct Xa inhibitors comparing change in coagulation and fibrinolysis factors during catheter invasion in patients with atrial fibrillation. - DA-PUNC

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031190030

Enrollment

Registered

2019-05-27

Start date

2019-08-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

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. (2.5m

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion 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 =3, left ventricular ejection fraction <= 35% or hospitalization due to heart failure within 1 year) Nutritional disorders Cancer

Design outcomes

Primary

Measure	Time frame
Change amount of prothrombin fragment 1+2 (F1+2) before and after blood vessel puncture during catheter ablation	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactYasuhiro Ikami

Niigata University Graduate School of Medical and Dental Sciences

yasu.ik@gmail.com+81-25-227-2185

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026