EUCTR2014-002236-14-DEActive, not recruitingPhase 1
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
niversity Hospital Ulm0 sites40 target enrollmentStarted: August 19, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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