Clinical trials: Non Valvular Atrial Fibrillation
Atrial Fibrillation
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.
- Trial name
- NCT02061748
- Testing
- Observational
- Where
- United States
- Volunteers
- 38,499 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).
- Trial name
- NCT00494871
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- 165 sites in Japan
- Volunteers
- 1,280 people
- Sponsor
- Bayer
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based…
- Trial name
- ELIMINATE-AF (NCT02942576)
- Testing
- Edoxaban, VKA-Based Regimen
- Where
- 75 sites in Belgium, Canada and 9 more
- Volunteers
- 632 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Non-valvular Atrial Fibrillation
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks
- Trial name
- AEGEAN (NCT01884350)
- Testing
- Apixaban
- Where
- 220 sites in Belgium, France and 5 more
- Volunteers
- 1,217 people
- Sponsor
- Bristol-Myers Squibb
Coronary Artery Disease, Atrial Fibrillation
A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin
The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant…
- Trial name
- NCT05051904
- Where
- Germany
- Volunteers
- 39,357 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are…
- Trial name
- PINNACLE FLX (NCT02702271)
- Testing
- WATCHMAN FLX
- Where
- 29 sites in United States
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal…
- Trial name
- NCT01136408
- Testing
- Dabigatran etexilate, Warfarin
- Where
- 28 sites in Japan
- Volunteers
- 174 people
- Sponsor
- Boehringer Ingelheim
Stroke
AMPLATZER™ Amulet™ LAA Occluder Trial
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial…
- Trial name
- Amulet IDE (NCT02879448)
- Testing
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- Where
- 115 sites in United States, Australia and 9 more
- Volunteers
- 1,878 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin).
- Trial name
- NCT00829933
- Testing
- DU-176b tablets, Warfarin potassium tablets
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.
- Trial name
- NCT01774370
- Testing
- Pradaxa (Dabigatran etexilate mesilate)
- Where
- South Korea
- Volunteers
- 3,182 people
- Sponsor
- Boehringer Ingelheim
The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation
WATCHMAN FLX™ CT Study
WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the…
- Trial name
- NCT05324371
- Testing
- Watchman FLX Device
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain
This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.
- Trial name
- NCT03993119
- Testing
- Non-vitamin K antagonist oral anticoagulant
- Where
- 45 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be…
- Trial name
- NCT02240667
- Testing
- Dabigatran etexilate, Vitamin K antagonists
- Where
- Germany
- Volunteers
- 1,506 people
- Sponsor
- Boehringer Ingelheim
Non-valvular Atrial Fibrillation
The Conformal Prague Study
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
- Trial name
- NCT04193826
- Testing
- Left Atrial Appendage Closure
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Conformal Medical, Inc
Atrial Fibrillation, Medication Adherence
Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF).
- Trial name
- NCT02690649
- Testing
- Health Messaging (Non-Procedural)
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Tammy Toscos
Atrial Fibrillation, Stroke
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
- Trial name
- NCT00262600
- Testing
- warfarin, Dabigatran dose 1, Dabigatran dose 2
- Where
- 984 sites in United States, Argentina and 42 more
- Volunteers
- 18,113 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation
This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or…
- Trial name
- ENTICED-AF (NCT02561897)
- Testing
- Edoxaban, Warfarin
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Electrophysiology Research Foundation
Atrial Fibrillation, Stroke
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis.
- Trial name
- NCT00806624
- Testing
- DU-176b tablets, Warfarin tablets
- Where
- 4 sites in China, Singapore and 2 more
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Treatment Pattern of Oral Anticoagulants (OAC) in Japan
1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients 2.
- Trial name
- NCT02982863
- Where
- Japan
- Volunteers
- 48,696 people
- Sponsor
- Boehringer Ingelheim