NCT02591225 is a Phase 4 clinical trial of Dabigatranetexilate in Atrial Fibrillation, sponsored by University of Ulm.

Who is sponsoring NCT02591225?

NCT02591225 is sponsored by University of Ulm.

What drugs are being tested in NCT02591225?

Interventions in NCT02591225: Dabigatranetexilate, Phenprocoumon.

What condition does NCT02591225 study?

NCT02591225 studies Atrial Fibrillation, Left Atrial Thrombosis.

Is NCT02591225 still recruiting?

NCT02591225 is currently status unknown. Last updated 12 November 2015.

Last reviewed 2015-11-12 · How we verify

NCT02591225

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phenprocoumon Versus Dabigatran in Subjects With Atrial Fibrillation and Left Atrial Thrombus - a Prospective, Randomized, Controlled, Open-label One Year Follow-up Pilot Study

Status unknown Phase 4 Last updated 12 November 2015

What this trial tests

Phase 4 trial testing Dabigatranetexilate in Atrial Fibrillation in 40 participants. Status unknown.

Timeline

1 October 2015

Primary endpoint
1 December 2017

Quick facts

Lead sponsor	University of Ulm
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 October 2015
Primary completion	1 December 2017
Sites	1 location across Germany

Drugs / interventions tested

Dabigatranetexilate — full drug profile →
Phenprocoumon — full drug profile →

Conditions studied

Atrial Fibrillation — all drugs for Atrial Fibrillation →
Left Atrial Thrombosis — all drugs for Left Atrial Thrombosis →

Sponsor

University of Ulm

Who can join

Adults 18 to 79, any sex, with Atrial Fibrillation or Left Atrial Thrombosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

left atrial thrombus resolution
Time frame: 12 months
thrombus size evaluated by transeshophageal echocardiography

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02591225 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Ulm
Last refreshed: 12 November 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02591225.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing