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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005364-26 | EudraCT Number |
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Recruiting problems
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Atrial Fibrillation Network | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | Experimental | Dabigatran etexilate (Pradaxa®) 150 mg capsule by mouth twice daly for 3 up to 6 weeks depending on treatment response |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Rostock, MD | University Medical Center of the Johannes Gutenberg-University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Heart Center; Department of Cardiology and Angiology II | Bad Krozingen | D-79189 | Germany | |||
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| Phenprocoumon | Drug | 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. |
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| 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. | 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. | 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:
| 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. | 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. | 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. | 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. | 3 up to 6 weeks |
| Charité Universitätsmedizin Berlin |
| Berlin |
| 10117 |
| Germany |
| Vivantes Clinical Center Am Urban; General Internal Medicine and conservative intensive care | Berlin | D-10967 | Germany |
| Klinikum Coburg GmbH | Coburg | 96450 | Germany |
| University Heart Center; Department of Cardiology | Cologne | D-50937 | Germany |
| University Heart Center; Department of Invasive Electrophysiology | Dresden | D-01307 | Germany |
| University Heart Center; Department of Cardiology, Electrophysiology | Hamburg | D-20246 | Germany |
| Hannover Medical School; Department of Cardiology and Angiology | Hanover | D-30625 | Germany |
| Städtisches Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Universitätsmedizin Leipzig | Leipzig | 04103 | Germany |
| University Hospital Mainz, II. Medical Clinic, Dept. of Electrophysiology | Mainz | D-55131 | Germany |
| University Medical Center | Münster | D-48149 | Germany |
| St. Vincenz-Hospital GmbH | Paderborn | D-33098 | Germany |
| Rostock University Hospital; Rhythmology and Clinical Electrophysiology | Rostock | D-18057 | Germany |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D010644 | Phenprocoumon |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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