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Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon

NCT02591225 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-11-13

No results posted yet for this study

Summary

This is a single-center, randomized, two treatment groups, open, phase IV clinical study in subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit) subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be performed followed by randomization to one of the two treatment groups (Phenprocoumon or Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at this visit. If the subject was randomized in the VKA group routinely INR measurements will performed.

Conditions

Interventions

DRUG

Dabigatranetexilate

After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.

DRUG

Phenprocoumon

After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.

Sponsors & Collaborators

Principal Investigators

  • Peter Bernhardt, MD · University Hospital Ulm, Department of Internal Medicine II

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591225 on ClinicalTrials.gov