Evaluation of a Pharmacogenetic-based Warfarin Dosing Algorithm in Patients
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|ClinicalTrials.gov Identifier: NCT02592980|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Genetic: Pharmacogenetic anticoagulation Drug: Traditional anticoagulation||Phase 4|
Investigators will recruit 300 patients with low TTR (<50%) from the Heart Institute- Clinical Hospital- University of São Paulo Medical School (InCor- HCFMUSP). The patients will be randomized into two groups: Traditional Anticoagulation (TA) group and Pharmacogenetic Anticoagulation (PA) group. The study protocol was approved by the Ethics Committee for Medical Research on Human Beings of the Clinical Hospital of the University of São Paulo Medical School (SDC 4033/14/013). Signed informed consent will be obtained from all participants.
Only patients with atrial fibrillation, above 18 years, and with TTR <50% based on the last three values of INR will be included in this study. Patients will not be included if they have reached a stable dose of warfarin, liver dysfunction, alcoholism, use of another anticoagulant, use of chemotherapy, or if they do not meet the inclusion criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of a Pharmacogenetic-based Warfarin Dosing Algorithm in Patients With Low Time in Therapeutic Range - Study Design|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Traditional anticoagulation
For the Traditional Anticoagulation group, the physician will adjust the dose according to the current INR value based on current guidelines
Drug: Traditional anticoagulation
The physician will adjust the dose according to current INR value based on guidelines.
Other Name: Warfarin
Experimental: Pharmacogenetic anticoagulation
For the Pharmacogenetic Anticoagulation group, the dose will be prescribed based on data from each patient applied in a pharmacogenetic algorithm. In some cases, used algorithm may provide a counter-intuitive dose, i.e., a dose that is not adequate for adjusting the current patient' INR (for example, a higher dose for a patient that already has a high INR). In these cases, the physician will adjust the dose following clinical criteria based on published guidelines
Genetic: Pharmacogenetic anticoagulation
The investigators use a algorithm pharmacogenetic for adjust only the first dose in the study.
Other Name: Warfarin
- time to achieve the therapeutic target [ Time Frame: 12 weeks ]time to achieve the therapeutic target during 12 weeks of treatment
- TTR (time in the therapeutic range) [ Time Frame: 4 weeks and 12 weeks ]TTR mean of 4 week and 12 week
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): NCT02592980
|Sao Paulo, Brazil, 05403900|
|Principal Investigator:||Alexandre Pereira, M.Sc||Laboratório de Genética e Cardiologia Molecular - Instituto do Coração|