- |||||||||| rivaroxaban / Generic mfg., apixaban / Generic mfg.
Journal: Doses of Apixaban and Rivaroxaban Prescribed in Real-World United States Cardiology Practices Compared to Registration Trials. (Pubmed Central) - Sep 13, 2017 Of all prescriptions written by cardiologists for these agents, 20.8% of apixaban and 21.7% of rivaroxaban prescriptions were for a reduced dose; corresponding to a 4.4-fold (16.1% absolute) increase in use of reduced dose apixaban and a 3% relative (0.6% absolute) increase in reduced dose rivaroxaban use vs. their respective registration trials. Further research is needed to better understand appropriate dosing of patients with novel anticoagulants.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Enrollment closed, Enrollment change: A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa (clinicaltrials.gov) - Sep 11, 2017 P1, N=153, Active, not recruiting, Initiation date: Jul 2017 --> Oct 2017 | Trial primary completion date: May 2021 --> Aug 2021 Recruiting --> Active, not recruiting | N=77 --> 153
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo
New trial, HEOR: The DARE Warfarin CER Study (clinicaltrials.gov) - Sep 5, 2017 P=N/A, N=416000, Enrolling by invitation,
- |||||||||| rivaroxaban / Generic mfg.
Trial primary completion date: CASTA-DIVA: Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban (clinicaltrials.gov) - Aug 29, 2017 P3, N=200, Recruiting, In conclusion, although the overall use of non-DHP CCBs was associated with an increased risk of major bleeding and intracranial hemorrhage, the use was not associated with a significant change in the safety or efficacy of rivaroxaban compared with warfarin observed in ROCKET AF. Trial primary completion date: May 2017 --> Mar 2018
- |||||||||| rivaroxaban / Generic mfg., dabigatran etexilate / Generic mfg., apixaban / Generic mfg.
Retrospective data, Trial primary completion date: The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis (clinicaltrials.gov) - Aug 21, 2017 P=N/A, N=47000, Recruiting, Among low-risk PE patients identified by using sPESI, Hestia or IMPACT, rivaroxaban was associated with significantly shorter LOS and lower hospital treatment costs versus heparin bridging to warfarin. Trial primary completion date: Jun 2017 --> Sep 2017
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim
New trial, Surgery, Claims database: Medical Need of OAC Reversal (clinicaltrials.gov) - Aug 18, 2017 P=N/A, N=62888, Not yet recruiting,
- |||||||||| rivaroxaban / Generic mfg.
Journal: Hospitalizations in patients with atrial fibrillation: an analysis from ROCKET AF. (Pubmed Central) - Aug 17, 2017 Nearly 1 in 7 of the moderate-to-high-risk patients with AF enrolled in this trial was hospitalized within 2 years, and both AF and bleeding were rare causes of hospitalization. Further research is needed to determine whether care pathways directed at comorbid conditions among AF patients could reduce the need for and costs associated with hospitalization.
- |||||||||| rivaroxaban / Bayer, Generic mfg.
Journal: Rivaroxaban for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Active Cancer. (Pubmed Central) - Aug 12, 2017 One patient died after developing an acute ischemic cerebrovascular insult. In conclusion, the safety and efficacy of rivaroxaban treatment for nonvalvular AF in patients with active cancer is comparable to the results of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) study in the general population.
- |||||||||| rivaroxaban / Generic mfg., apixaban / Generic mfg.
Biomarker, Enrollment open: DAPHNE Study: Direct Anticoagulant PHarmacogeNEtic (clinicaltrials.gov) - Jul 28, 2017 P=N/A, N=350, Recruiting, Real-world analysis of oral anticoagulant use may reveal whether the relatively high persistence/low discontinuation demonstrated for rivaroxaban translates into lower rates of stroke. Not yet recruiting --> Recruiting
- |||||||||| rivaroxaban / Generic mfg., enoxaparin sodium / Generic mfg.
Trial primary completion date, Surgery: PRONOMOS: PROphylaxis in NOn Major Orthopaedic Surgery (clinicaltrials.gov) - Jul 19, 2017 P3, N=4400, Recruiting, Initiation date: Jun 2017 --> May 2014 | Trial primary completion date: Dec 2020 --> Jul 2017 Trial primary completion date: Jun 2017 --> Mar 2018
- |||||||||| Fraxiparine (nadroparin) / Aspen
Enrollment open, Trial initiation date, Metastases: Anticoagulation for Advanced Cirrhotic Patients After TIPS (clinicaltrials.gov) - Jul 14, 2017 P=N/A, N=254, Recruiting, We found that patients with AF and AS on oral anticoagulants may have distinctly different efficacy and safety outcomes than patients with MR or AR or no SVD. Not yet recruiting --> Recruiting | Initiation date: Jan 2017 --> Jun 2017
- |||||||||| rivaroxaban / Generic mfg., dabigatran etexilate / Generic mfg., apixaban / Generic mfg.
Enrollment closed, Enrollment change, Surgery: BRUISECONTROL2: Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (clinicaltrials.gov) - Jun 27, 2017 P3, N=663, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=846 --> 663
- |||||||||| rivaroxaban / Generic mfg., dabigatran etexilate / Generic mfg., apixaban / Generic mfg.
Enrollment closed, Trial primary completion date: Use of Direct Oral Anticoagulants in UK (clinicaltrials.gov) - May 23, 2017 P=N/A, N=3000, Active, not recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Active, not recruiting | Trial primary completion date: May 2017 --> Aug 2017
- |||||||||| rivaroxaban / Generic mfg., Savaysa (edoxaban) / Daiichi Sankyo, apixaban / Generic mfg.
Journal: Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants (DOACs): A Systematic Review. (Pubmed Central) - May 14, 2017 In the absence of these tests, TT or APTT is recommended over PT/INR for assessment of dabigatran, and PT/INR is recommended over APTT for detection of factor Xa inhibitors. Time since last dose, the presence or absence of drug interactions, and renal and hepatic function should impact clinical estimates of anticoagulant effect in a patient for whom laboratory test results are not available.
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