A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLINDED ENDPOINT EVALUATION (PROBE) PARALLEL GROUP STUDY COMPARING EDOXABAN VS. VKA IN SUBJECTS UNDERGOING CATHETER ABLATION OF NON-VALVULAR ATRIAL FIBRILLATIO
- Conditions
- atrial fibrillationirregular heartbeat10007521
- Registration Number
- NL-OMON45248
- Lead Sponsor
- Daiichi Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
1. Male or female at least 18 years of age with documented history of paroxysmal (lasting *7 days), persistent (lasting >7 days but *12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject*s medical records (e.g., medical chart, hospital discharge summary).
2. Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
3. Signed informed consent form (ICF).
1. AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
2. Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
3. Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
4. Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
5. Subject has signs of bleeding, history of clinically-relevant bleeding according to ISTH, or conditions associated with high risk of bleeding such as past history of intracranial (spontaneous or traumatic), or spontaneous intraocular, spinal, retroperitoneal, or intra-articular bleeding; overtgastrointestinal (GI) bleeding or active ulcer within the previous year; recent severe trauma, major surgery, or deep organ biopsy; active infective endocarditis; uncontrolled hypertension (blood pressure [BP] above 170/100 mmHg); or hemorrhagic disorder including known or suspected hereditary or acquired bleeding or coagulation disorder in the last 12 months prior to randomization.
6. Subjects with mechanical heart valves, subjects with moderate to severe mitral stenosis and subjects who have new implantation (within 3 months prior to randomization) of a bioprosthetic heart valve, with or without AF.
7. Subjects with a history of LAA occlusion/exclusion (either by surgery or by a procedure).
8. Subjects with any contraindication for edoxaban, VKA, LMWH, heparin therapy.
9. Subjects receiving dual antiplatelet therapy (DAPT, i.e., aspirin and P2Y12 antagonist) or planned to receive DAPT during the study
10. Subjects who require chronic use of medicines affecting hemostasis such as higher doses of aspirin (acetylsalicylic acid [ASA]) (ASA up to 100 mg per day allowed) or chronic oral or parenteral intake of non-aspirin non-steroidal anti-inflammatory drugs (NSAID) on *4 days/week (use of NSAIDs via other routes is not restricted)
11. Subjects with active liver disease or persistent (confirmed by repeat assessments at least a week apart) elevation of liver enzymes/bilirubin:
* Alanine transaminase (ALT) or aspartate transaminase (AST) *2 times the upper limit of normal (ULN)
* Total bilirubin (TBL) *1.5 times the ULN (subjects whose elevated TBL is due to known Gilbert*s syndrome may be included in the study)
* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
12. Subjects with kidney failure (calculated creatinine clearance [CrCL] <15 mL/min).
13. Subjects with hemoglobin <10 g/dL or platelet count <100,000 cells/*L or white blood cell (WBC) count <3000 cells/*L.14. Subjects with pre-planned invasive diagnostic or therapeutic procedures/interventions (other than endoscopy) during the study period in which bleeding is anticipated.
15. Participation in any other interventional trial (subjects who received any investigational drug or device within 30 days prior to randomization, or plan to receive such investigational therapy during the study period).
16. Previous randomization in this study.
17. Female subjects of childbearing potential without using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy endpoint<br /><br>Composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined),<br /><br>and Major Bleeding (ISTH), analyzed as time to first<br /><br>occurrence of any component<br /><br><br /><br>Primary safety endpoint<br /><br>Major Bleeding (ISTH), analyzed as time to first occurrence of Major Bleeding</p><br>
- Secondary Outcome Measures
Name Time Method