Phenprocoumon versus Dabigatran in subjects with atrial fibrillation and left atrial thrombus - a prospective, randomized, controlled, open-label one year follow-up pilot study

Phenprocoumon versus Dabigatran in subjects with atrial fibrillation and left atrial thrombus - a prospective, randomized, controlled, open-label one year follow-up pilot study - Thrombus-Reduction

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002236-14-DE

Enrollment

Registered

2015-08-19

Start date

2015-10-28

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

left atrial thrombus

Interventions

Product Name: Dabigatran Pharmaceutical Form: Capsule Product Name: Phenprocoumon Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects at an age =18 years both gender - Signed and dated written informed consent - Atrial fibrillation (new, paroxysmal, persistent or permanent) - Left atrial thrombus evaluated by TEE within 7 days prior enrollment - Negative pregnancy test in woman with childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Age = 80 years - Low body weight < 50 kg - Instable cardiac or respiratory condition - Contraindication for Phenprocoumon or Dabigatran (Reference to current SmPC) - Severely reduced renal function (CrCl < 30 ml/min according to Cockcroft-Gault) - Inadequate hepatic function (AST and ALT higher than 2x ULN) - Contraindication for MRI - Pregnant or nursing woman, or sexually active woman of childbearing potential

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare Phenprocoumon and Dabigatran for the reduction of left atrial (LA) thrombus size (primary objective) and silent cerebral embolism (secondary objective).;Secondary Objective: Bleeding events;Primary end point(s): none - Pilot study;Timepoint(s) of evaluation of this end point: not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Germany

Contacts

Public ContactPeter Bernhardt

University Hospital Ulm, Department of Internal Medicine II

peter.bernhardt@uniklinik-ulm.de00490731500-45060

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026