Atrial Fibrillation or Atrial FlutterPhase 2RE-LATED_AFNCT02256683

Resolution of Left Atrial-Appendage Thrombus - Effects of Dabigatran in Patients With AF

A Phase 2 study testing Dabigatran etexilate and Phenprocoumon in people with Atrial Fibrillation or Atrial Flutter and Thrombosis of Left Atrial Appendage, run by Johannes Gutenberg University Mainz at 14 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Atrial Fibrillation or Atrial Flutter, Thrombosis of Left Atrial Appendage
What is being tested?: Dabigatran etexilate and Phenprocoumon
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 14 sitesGermany
Study dates: Jul 2014to May 2018
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with documented non-valvular AF or atrial flutter (12-lead ECG)
Newly diagnosed or confirmed LAA thrombus in TEE (time of detection ≤ 28 days)
Patients 18 years old
CHA2DS2-VASc Score 1
CrCL 30 mL/min (Cockcroft-Gault)
Women with childbearing potential have to practice a medically accepted contraception
Ability of patient to understand the character and the individual consequences of the clinical trial
Signed and dated informed consent before start of any specific trial procedures

Who cannot join

Patients > 80 years
Low body weight (< 50 kg)
Previous failure of LAA thrombus resolution with a VKA or factor Xa antagonist
Occurrence of LAA thrombus under long-term treatment (> 3 months) with vitamin K antagonists with an exception in the case of continued INR out of the target range
Contraindications for oral anticoagulation therapy (see current Fachinformation for Pradaxa® (150 mg) and Marcumar® (3 mg))
History of heart valve disorder (i.e., prosthetic valve or hemodynamically relevant valve disease)

Show all 35Show fewer

Valvular heart disease requiring intervention (including mechanical valves)
Acute myocardial infarction or MI within the last 26 weeks
Acute coronary syndrome (e.g. instable angina pectoris, STEMI, NSTEMI)
Chronic Heart Failure (> NYHA IIIa)
Previous haemorrhagic stroke
TIA within the last 90 days
Clinical relevant bleeding within the last 26 weeks
Acute and subacute bacterial endocarditis
Recurrent pulmonary embolism
Esophagitis, gastritis and gastroesophageal reflux
Thrombocytopenia or functional platelet defects
Congenital or acquired coagulation or haemorrhagic disorders
Liver diseases (liver enzymes >2 ULN)
Renal insufficiency (CrCL below 30 mL/min)
Pre-treatment with Dabigatran in doses higher than 110 mg bid
Concomitant treatment with rivaroxaban, apixaban, and in case of approval during the course of the trial, also edoxaban
Concomitant treatment with irreversible cyclooxygenase inhibitors (e.g. ASA) at doses > 100 mg/d.
Concomitant treatment with high doses of Adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel) at doses > 75 mg/d
Combined treatment with Adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel) and irreversible cyclooxygenase inhibitors (e.g. ASA) in any dose combination
Planned treatment with long-term oral anticoagulants for alternative indications
Concomitant treatment with P-glycoprotein (P-gp) inhibitors, i.e. verapamil.
Need for continued treatment with ticlopidine, ticagrelor, prasugrel, systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic/myelosuppressive therapy
Concomitant treatment with medication not permitted
Planned surgical intervention during expected study participation or previous surgical interventions within the last 30 days
Other significant risk factors for bleeding complications (e.g. malignancy)
Pregnancy and lactation.
History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
Participation in other clinical trials during the present clinical trial or within the last 90 days.
Medical or psychological condition that would not permit completion of the trial or signing of informed consent.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Germany14 sites

University Heart Center; Department of Cardiology and Angiology II
Bad Krozingen, D-79189
Charité Universitätsmedizin Berlin
Berlin, 10117
Vivantes Clinical Center Am Urban; General Internal Medicine and conservative intensive care
Berlin, D-10967
Klinikum Coburg GmbH
Coburg, 96450
University Heart Center; Department of Cardiology
Cologne, D-50937
University Heart Center; Department of Invasive Electrophysiology
Dresden, D-01307
University Heart Center; Department of Cardiology, Electrophysiology
Hamburg, D-20246
Hannover Medical School; Department of Cardiology and Angiology
Hanover, D-30625
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Universitätsmedizin Leipzig
Leipzig, 04103
University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology
Mainz, D-55131
University Medical Center
Münster, D-48149
St. Vincenz-Hospital GmbH
Paderborn, D-33098
Rostock University Hospital; Rhythmology and Clinical Electrophysiology
Rostock, D-18057

Other trials in Germany

About this study

Official title: Effects of Dabigatran in Patients With AF - A Prospective, Randomized, Open-label, Explorative, Blinded-endpoint Trial to Compare the Efficacy of Dabigatran With Phenprocoumon for the Resolution of LAA Thrombus in Patients With AF

The primary objective of this study is to assess whether Dabigatran leads to a faster complete left atrial appendage (LAA) thrombus resolution as compared to Phenprocoumon. The secondary objectives of this trial are to assess the impact of Dabigatran versus Phenprocoumon on complete LAA thrombus resolution rate until week 6 and change in LAA thrombus volume under treatment as well as to assess and compare safety and tolerability of both drugs. A total of 110 patients with atrial fibrillation and LAA thrombus will be randomized to receive either Dabigatran (150 mg bid) or Phenprocoumon (INR 2-3) for a least three weeks. Thrombus resolution will be determined by transoesophageal echocardiography (TEE) 3 weeks after start of study treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus. For those patients whose thrombus still exists after 6 weeks treatment, the study is also terminated. Further treatments will be decided at the discretion of the treating physician.

Read the detailed description

BACKGROUND Dabigatran etexilate, a direct thrombin inhibitor and new oral anticoagulant (NOAC), has been shown to effectively prevent thromboembolic events in patients with atrial fibrillation (AF). However, there is a paucity of data on the antithrombotic efficacy and safety of dabigatran in the resolution of left atrial appendage (LAA) thrombi in AF patients.

OBJECTIVE The primary objective of the RE-LATED trial is to assess whether treatment with dabigatran results in a faster complete LAA thrombus resolution as compared to vitamin-K antagonist phenprocoumon. Secondary objectives are to assess the impact of dabigatran on complete LAA thrombus resolution rate during treatment of 6 weeks, and change in LAA thrombus volume under treatment. Furthermore, this study aims to assess and compare safety and tolerability of dabigatran vs. phenprocoumon.

METHODS The study is designed as a prospective, multicenter, randomized, open-label, controlled, explorative, blinded endpoint (PROBE) trial. Patients with AF and left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) will be randomized to receive either dabigatran (150 mg bid) or phenprocoumon (INR 2-3) for the resolution of LAA thrombus formation for at least 21 days. Thrombus resolution will be determined by TEE 3 weeks after treatment initiation and subsequently at week 4 and 6, if the primary study endpoint (LAA thrombus resolution) has not yet been achieved. A total of 110 patients are planned to get randomized.

CLINICAL CONTEXT This is the first controlled trial that investigates the safety and efficacy of a NOAC for the resolution of a LAA thrombus in patients with AF.

Conditions: Atrial Fibrillation or Atrial Flutter, Thrombosis of Left Atrial Appendage
Being tested: Dabigatran etexilate, Phenprocoumon
Keywords: atrial fibrillation, atrial flutter, Atrial-Appendage Thrombus, Thrombus resolution, Dabigatran, Phenprocoumon, Transesophageal Echocardiography
Medical subject headings: Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dabigatran etexilateDrug
Also called Pradaxa®
After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.
PhenprocoumonDrug
Also called Marcumar®
After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.

Study groups in NCT02256683
Study group	Role	What they receive
Dabigatran	Experimental	Dabigatran etexilate (Pradaxa®) 150 mg capsule by mouth twice daly for 3 up to 6 weeks depending on treatment response Receives: Drug: Dabigatran etexilate
Phenprocoumon	Active comparator	Phenprocoumon (Marcumar®) 3 mg capsule by mouth according to INR (2-3) for 3 up to 6 weeks depending on treatment response Receives: Drug: Phenprocoumon

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to complete left atrial appendage (LAA) thrombus resolution
Transoesophageal echocardiography (TEE) will be performed at screening and after three weeks of treatment. In case of persistence of the LAA thrombus after three weeks, study treatment will be continued for a maximum of further 3 weeks and the patients will undergo a TEE at weeks 4 and 6 for LAA thrombus assessment until LAA thrombus resolution can be confirmed. The study is finished for each patient with the resolution of the LAA thrombus. For patients with a thrombus persisting after 6 weeks treatment, the study will also be terminated.
At each TEE examination existence of a LAA thrombus is documented (YES/NO).
Measured: 3 up to 6 weeks

Secondary outcomes (8)

Complete LAA thrombus resolution until week 6 (yes/no)
Transoesophageal echocardiography (TEE) will be performed at screening and after three weeks of treatment. In case of persistence of the LAA thrombus after three weeks, study treatment will be continued for a maximum of further 3 weeks and the patients will undergo a TEE at weeks 4 and 6 for LAA thrombus assessment until LAA thrombus resolution can be confirmed. The study is finished for each patient with the resolution of the LAA thrombus. For patients with a thrombus persisting after 6 weeks treatment, the study will also be terminated.
At each TEE examination existence of a LAA thrombus is documented (YES/NO).
Measured: 3 up to 6 weeks
Change in LAA thrombus volume under treatment
Transoesophageal echocardiography (TEE) will be performed at screening and after three weeks of treatment. In case of persistence of the LAA thrombus after three weeks, study treatment will be continued for a maximum of further 3 weeks and the patients will undergo a TEE at weeks 4 and 6 for LAA thrombus assessment until LAA thrombus resolution can be confirmed. The study is finished for each patient with the resolution of the LAA thrombus. For patients with a thrombus persisting after 6 weeks treatment, the study will also be terminated.
If a LAA thrombus exists the longitudinal and transversal diameters (mm) in the 45-60° and in the 135° layer are measured.
If a LAA thrombus exists based on the diameters the volume (mm3) of the LAA thrombus is calculated.
Measured: 3 up to 6 weeks
Occurrence of any adverse event
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Measured: 3 up to 6 weeks
Occurrence of major bleedings
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Criteria for major bleedings in non-surgical patients:
1. Fatal bleeding, and/or
2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or
3. Bleeding causing a fall in haemoglobin level of 2.0 g/dl (1.24 mmol/l) or more, or leading to transfusion of two or more units of whole blood or red cells.
Measured: 3 up to 6 weeks
Occurrence of strokes (all-type, haemorrhagic, ischemic) ascertained by CCT or cMRT
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Measured: 3 up to 6 weeks
Occurrence of transient ischaemic attacks (TIAs)
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Measured: 3 up to 6 weeks
Occurrence of cardiovascular events requiring hospitalization
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Measured: 3 up to 6 weeks
Occurrence of other thromboembolic events
Patient interview at each visit and at follow up phone call. In case of availability review of patients' health records.
Measured: 3 up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014May 2018

First posted6 Oct 2014 (estimated)
Study startJul 2014
Primary completionMay 2018
Study completionMay 2018

Why it stopped: Recruiting problems

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial Fibrillation or Atrial FlutterStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256683
Sponsor's protocol ID: 2013-008
Other IDs: 2013-005364-26
Acronym: RE-LATED_AF
Status last verified: Jul 2019
First submitted: 12 Sep 2014
Last updated: 26 Jul 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Dabigatran in Patients With AF - A Prospective, Randomized, Open-label, Explorative, Blinded-endpoint Trial to Compare the Efficacy of Dabigatran With Phenprocoumon for the Resolution of LAA Thrombus in Patients With AF
ClinicalTrials.gov ID: NCT02256683
Acronym / sponsor ID: RE-LATED_AF / 2013-008
Conditions: Atrial Fibrillation or Atrial Flutter, Thrombosis of Left Atrial Appendage
Keywords: atrial fibrillation, atrial flutter, Atrial-Appendage Thrombus, Thrombus resolution, Dabigatran, Phenprocoumon, Transesophageal Echocardiography
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruiting problems
Enrolment: 64 participants (actual)
Lead sponsor: Johannes Gutenberg University MainzUniversity, hospital or other
Collaborators: Boehringer Ingelheim, Atrial Fibrillation Network
Study start: Jul 2014
Primary completion: May 2018 (actual)
Study completion: May 2018 (actual)
First posted: 6 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

CLINICAL CONTEXT This is the first controlled trial that investigates the safety and efficacy of a NOAC for the resolution of a LAA thrombus in patients with AF.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dabigatran	Experimental	Drug: Dabigatran etexilateDabigatran etexilate (Pradaxa®) 150 mg capsule by mouth twice daly for 3 up to 6 weeks depending on treatment response
Phenprocoumon	Active comparator	Drug: PhenprocoumonPhenprocoumon (Marcumar®) 3 mg capsule by mouth according to INR (2-3) for 3 up to 6 weeks depending on treatment response

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with documented non-valvular AF or atrial flutter (12-lead ECG)
Newly diagnosed or confirmed LAA thrombus in TEE (time of detection ≤ 28 days)
Patients 18 years old
CHA2DS2-VASc Score 1
CrCL 30 mL/min (Cockcroft-Gault)

Key exclusion criteria (35 listed)

Patients > 80 years
Low body weight (< 50 kg)
Previous failure of LAA thrombus resolution with a VKA or factor Xa antagonist
Occurrence of LAA thrombus under long-term treatment (> 3 months) with vitamin K antagonists with an exception in the case of continued INR out of the target range
Contraindications for oral anticoagulation therapy (see current Fachinformation for Pradaxa® (150 mg) and Marcumar® (3 mg))

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dabigatran etexilateAlso: Pradaxa®After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.	Drug	Dabigatran
PhenprocoumonAlso: Marcumar®After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.	Drug	Phenprocoumon

Primary outcome

Time to complete left atrial appendage (LAA) thrombus resolution
Time frame: 3 up to 6 weeks
Transoesophageal echocardiography (TEE) will be performed at screening and after three weeks of treatment. In case of persistence of the LAA thrombus after three weeks, study treatment will be continued for a maximum of further 3 weeks and the patients will undergo a TEE at weeks 4 and 6 for LAA thrombus assessment until LAA thrombus resolution can be confirmed. The study is finished for each patient with the resolution of the LAA thrombus. For patients with a thrombus persisting after 6 weeks treatment, the study will also be terminated. At each TEE examination existence of a LAA thrombus is documented (YES/NO).

8 secondary outcomes

Complete LAA thrombus resolution until week 6 (yes/no)
Time frame: 3 up to 6 weeks
Change in LAA thrombus volume under treatment
Time frame: 3 up to 6 weeks
Occurrence of any adverse event
Time frame: 3 up to 6 weeks
Occurrence of major bleedings
Time frame: 3 up to 6 weeks
Occurrence of strokes (all-type, haemorrhagic, ischemic) ascertained by CCT or cMRT
Time frame: 3 up to 6 weeks
Occurrence of transient ischaemic attacks (TIAs)
Time frame: 3 up to 6 weeks
Occurrence of cardiovascular events requiring hospitalization
Time frame: 3 up to 6 weeks
Occurrence of other thromboembolic events
Time frame: 3 up to 6 weeks

Results and safety

The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Rostock, MD principal investigator

University Medical Center of the Johannes Gutenberg-University Mainz

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruiting problems). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to complete left atrial appendage (LAA) thrombus resolution (time frame: 3 up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.