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

Phase 1

Conditions: left atrial thrombus
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-002236-14-DE

Lead Sponsor: niversity Hospital Ulm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures