Randomized Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of an uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)
- Conditions
- 1000318410047079non-valvular atrial fibrillation and pulmonary vein ablation10007521
- Registration Number
- NL-OMON42157
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
- Male or female patients aged ><=18 years.
- Patients eligible for treatment with dabigatran etexilate 150 mg b.i.d. according to local label.
- Treatment naïve patients or patients on oral anticoagulant treatment with a VKA, dabigatran etexilate, rivaroxaban, apixaban or edoxaban.
- Patients with paroxysmal or persistent NVAF with a planned catheter ablation for AF unless it is performed an investigational ablation technique.
- AF must have been documented at least once within 24 months prior to screening (Visit 1).
- The patient must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations.
- Patients with permanent AF.
- Patients with AF felt to be secondary to an obvious reversible cause.
- Patients with LA size >= 60 mm
- Patients with contraindications to systemic anticoagulation with heparin, warfarin or dabigatran etexilate
- Patients with a known allergy to warfarin tablets and it excipients or to dabigatran etexilate or its excipients
- Mechanical or biological heart valve prosthesis
- Severe renal impairment
- Stroke within 1 month prior to screening visit
- Major surgery per investigator judgement within the previous month prior to screening.
- Patient has received an organ transplant or is on a waiting list for an organ transplant
- History of intracranial haemorrhage, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding
- Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the investigator, the cause has been permanently eliminated (e.g. by surgery).
- Major bleeding episode (ISTH definition) one month prior to the screening visit.
- Haemorrhagic disorder or bleeding diathesis
- Anaemia or thrombocytopenia including heparin-induced thrombocytopenia at screening
- Recent malignancy or radiation therapy (<=6 months prior to screening) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months
- Active liver disease
- Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John*s Wort or any cytotoxic/myelosuppressive therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for this trial is a safety endpoint:<br /><br>* The incidence of Major Bleeding Events according to the ISTH definition<br /><br>during the ablation procedure and up to 2 months post-ablation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints for this trial are the incidence of the following<br /><br>efficacy and safety<br /><br>endpoints:<br /><br>*- Stroke/SE/TIA events during the ablation procedure and up to 2 months<br /><br>post-ablation.<br /><br>*- Minor bleeding events during the ablation procedure and up to 2 months<br /><br>postablation.<br /><br>*- A composite of major bleeding events and thromboembolic events (Stroke, SE<br /><br>and TIA) during the ablation procedure and up to 2 months post-ablation.</p><br>