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Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam

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ClinicalTrials.gov Identifier: NCT03996629
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tien Hoang Tran, Ho Chi Minh City University of Medicine and Pharmacy

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anticoagulation Other: Patient education and compliance Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Clinical Pharmacist Interventions in Vitamin K Antagonists Management at One Teaching Hospital in Vietnam: A Randomized Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Arm Intervention/treatment
Experimental: Pharmacist-managed anticoagulation service Other: Patient education and compliance
When the patient is enrolled in the intervention group, pharmacists provide medical education about the pathophysiology, medications, lifestyle, how to prevent, recognize and take care of bleeding events, etc. Establish a medical record for every follow-up examination and remind follow-ups by message, phone every month.

No Intervention: Usual medical care



Primary Outcome Measures :
  1. Time in the therapeutic range (TTR) [ Time Frame: 12 months ]
    The time in the therapeutic range (TTR) has been used as a measure of warfarin therapy quality. The percentage of TTR is the percentage of the number of patient's INR achieved therapeutic range on the total number of patient's INR test in the 12-month follow-up of each patient.

  2. Bleeding events [ Time Frame: 12 months ]
    Major bleeding is considered to be those events that resulted in death or the need for acute medical or surgical intervention, also as defined by previously described criteria. Minor bleeding includes increased bruising on the skin and other bleeding episodes not meeting the criteria for major bleeding.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients received a discharge prescription with VKA therapy from November 2018
  • Patients agree to participate in the study
  • Age 18 and older
  • Duration of VKA therapy ≥12 months

Exclusion Criteria:

  • Patients with cognitive impairment as diagnosed by physician
  • Geographical and financial conditions do not allow patients to guarantee follow-up examination on schedule
  • Patient has less than 3 INR test results after the first day participating in the study
  • Cannot contact patient by phone call or face-to-face communication after the first day participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996629


Contacts
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Contact: Tien Hoang Tran, BSPharm 84 364 969 137 tien.th@umc.edu.vn

Locations
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Vietnam
University Medical Center Ho Chi Minh City Not yet recruiting
Ho Chi Minh City, Vietnam, 70000
Contact: Tien Hoang Tran, BSPharm    84 364 969 137    tien.th@umc.edu.vn   
Contact: Trang Dang, PhD    84 909 907 976    trang.dnd@umc.edu.vn   
Principal Investigator: Tien Hoang Tran, BSPharm         
Sponsors and Collaborators
Ho Chi Minh City University of Medicine and Pharmacy
Investigators
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Study Chair: Trang Dang, PhD University Medical Center Ho Chi Minh City

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Responsible Party: Tien Hoang Tran, Principal Investigator, Ho Chi Minh City University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03996629     History of Changes
Other Study ID Numbers: UMCAM01
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tien Hoang Tran, Ho Chi Minh City University of Medicine and Pharmacy:
pharmacist-managed anticoagulation
warfarin
acenocoumarol
Additional relevant MeSH terms:
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Vitamin K
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants