Anticoagulation Clinical Trial
Official title:
Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
For decades, vitamin K antagonists are the main oral anticoagulants used for primary and
secondary prevention of arterial and venous thromboembolic events. Both observational and
randomized controlled trials have confirmed an outstanding outcome (the percentage of time in
the therapeutic range-TTR, effectiveness and safety) in patients received anticoagulation
management provided by pharmacists (AMPP) in comparing with usual physician care.
However, at present, pharmacist-managed anticoagulation services are still not popular in
developing countries. In addition, there are few studies evaluating the patient outcomes with
the AMPP model in Vietnam. Above all, it is important to explore whether AMPP is superior to
other usual models in the improvement of effectiveness and safety.
The study is a randomized controlled trial. Patients who will use VKA are prospectively
divided into routine group and pharmacist intervention group.
For the intervention group, patients receive an intensive medical education from pharmacists
in anticoagulation management service. Pharmacists regularly provide telephone and outpatient
follow-up. At the end of the 12-month follow-up, the percentage of TTR and major bleeding
events will be evaluated in both groups.
Clinical data is designed to be collected from 800 patients, 400 patients in each group. Data
will be analyzed by SPSS 20.0 software. P < 0.05 is considered significant.
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