Atrial FibrillationNCT01318057
Pharmacogenetics of Warfarin in Puerto Ricans.
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
Warfarin (Coumadin) is a prescribed "blood thinner" medication used to make the blood less thick in people with high risk of forming blood clots. Despite the various methods to monitor this drug, life-threatening bleeding is a common undesired effect and might result in patient death. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Deep Vein Thrombosis, Cardiac Valvular Insufficiency
- How many people
- 350 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Feb 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hispanic Puerto Rican patients from all geographic regions of the Island of Puerto Rico who are currently receiving a standard stable dose of warfarin at the anticoagulation clinic of the Veteran Affair Caribbean Healthcare System (VACHS)
Who may be able to join
- Patients whose parents are both Puerto Ricans; male and female aged > 18 years old
- Scheduled to receive the standard 5 mg/day oral dose of warfarin for therapeutic anti-coagulation in indications such as deep vein thrombosis (DVT) with or without Pulmonary Embolism (PE)
- Atrial fibrillation (AF) or other arrhythmias, cardiac valvular replacement, and previously diagnosed coagulopathy
- Hematocrit (Hct) > 40%
- Blood Urea Nitrogen (BUN)/creatinine < 30/1.5 mg/dL
- Patients having the ability to understand the requirements of the study and to comply with study procedures and protocol
- Female patient is eligible to enter the study if she is of child-bearing potential but not pregnant or nursing, or not of child-bearing potential
Who cannot join
- Patients currently enrolled in another active research protocol at the Veteran Affairs Caribbean Healthcare System (VACHS) Hospital
- Blood Urea Nitrogen (BUN)/creatinine > 30/2.0 mg/dL
- Active hepatic disease (defined by a Child-Pugh score above 10 points)
- Ascites
- Total bilirubin above 2.0 mg/dl
- Serum albumin below 3.5 g/dl
Show all 13Show fewer
- Prothrombin time in seconds prolonged over control > 4
- Hepatic encephalopathy
- Prolonged diarrhea (three or more days)
- Nasogastric or enteral feedings
- Acute illness (e.g., sepsis, infection, anemia)
- Lymphocyte function test (LFT)> 3x upper limit of normal (ULN)
- Active malignancy
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Veteran Affair Caribbean Healthcare System
San Juan, 00921
About this study
Official title: Pharmacogenetics of Warfarin in Puerto Rican Patients Using a Physiogenomics Approach.
Warfarin (Coumadin) is a prescribed "blood thinner" medication used to make the blood less thick in people with high risk of forming blood clots. Despite the various methods to monitor this drug, life-threatening bleeding is a common undesired effect and might result in patient death. Patients starting warfarin therapy may require several weeks or even months to reach the appropriate blood level of warfarin. This blind practice could place the patient at high risk. There are several demographic and clinical factors that significantly influence how much warfarin the patient needs to attain the desired response. Genes, which control hereditary traits, are also important. Now, the investigators know that by using the information encoded in patient's genes the investigators are able to individualize the therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1). This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the investigators are able to determine the structure of the Puerto Rican population in terms of ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1 variants. Secondly, the investigators will assess the association of these variants to clinical responses in order to develop a better method of dose estimation. The expected result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill a gap in the knowledge of warfarin pharmacogenetics, providing new information on the prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as well as their role in the warfarin response variability observed in this admixed population.
Read the detailed description
Warfarin is a frequently prescribed drug for both the treatment and prevention of thromboembolic complications. Although many reports have been published over the past years in different populations worldwide, there is a fundamental gap in understanding whether variations in CYP2C9 and VKORC1 genes account for the inter-individual variability in response to warfarin that is observed in Puerto Rican patients. This study is a first step toward the development of DNA-driven personalized guidelines for warfarin dose optimization in Puerto Rican patients with thromboembolic complications. Guided by strong preliminary data, this application will pursuit two specific aims: 1) Develop a physiogenomic (PG)-driven admixture analysis of 350 samples from a population of warfarin-treated Puerto Rican patients using the PG array in order to study the pharmacogenetics of warfarin in Puerto Ricans and 2) Determine whether combinatorial CYP2C9 and VKORC1 genotypes are associated with clinical phenotypes during warfarin therapy in Puerto Rican patients. Under the first aim, 350 DNA specimens from warfarin-treated Puerto Rican patients who consent to participate in this study will be genotyped at large-scale using a novel Illumina-based PG-array of 222 candidate genes from relevant cardio-metabolic and neuro-endocrine pathways in order to examine the population structure of Puerto Ricans and create a reference database of individual admixture, allele frequencies, linkage disequilibrium (LD) and haplotypes for pharmacogenetics studies. Noteworthy, this information remains to be determined in Puerto Ricans. Under the second aim, demographic and clinically relevant non-genetic data will be retrospectively collected from medical records of these patients in order to perform an association analysis between their previously obtained CYP2C9 and VKORC1 genotypes and the corresponding time to achieve stable warfarin dosing following survival analysis techniques and Cox proportional hazards model. Accomplishment of this specific aim will also give the basis for developing a DNA-guided warfarin dosing algorithm in Puerto Rican by using these patients as a learning sample. The long-term goal is to generate valuable information from the genetic background of Puerto Ricans in order to further validate the pharmacogenetic-driven warfarin dosing algorithm for this admixed population. The proposed research is significant because it is expected to advance and expand understanding of how these clinically relevant variants affect the way people from an admixed, under-served population respond to warfarin. This is an important and under-investigated area of pharmacogenetics in minority populations that will have potential applicability to personalize warfarin therapy.
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Cardiac Valvular Insufficiency, Antiphospholipid Syndrome, Coagulopathy
- Keywords
- Pharmacogenetics, Warfarin, Personalized Medicine, Puerto Ricans, Physiogenomics, Hispanics, Anticoagulants, Cardiovascular, Deep Vein Thrombosis with or without Pulmonary Embolism, Cardiac Valvular Replacement
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Antiphospholipid Syndrome, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wild-Type | Wild-Type are those individuals who were non-carriers of any functional (loss-of-function)variant in CYP2C9 and/or VKORC1 genes | |
| Carriers | Those patients who were identified as having any functional CYP2C9 and/or VKORC1 polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to achieve stable warfarin dose
time to get a stable warfarin dose is defined by the time span (days) from the initial dose until achieving three consecutive INR measurements within therapeutic range (2-3 or 2.5-3.5, according to indication.
Measured: 6 months
Secondary outcomes (2)
time to first bleeding
time to first bleeding is defined as the time span (days) from the initiation of therapy until the first report of serious or life-threatening bleeding episode.
Measured: 6 months
time to first INR>4
time to first INR above 4 is an indicator of overanticoagulation that is defined as the time span (days) from the initiation of therapy until the first measurement of INR above 4.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Hartford Hospital, VA Caribbean Healthcare System
- Responsible party
- Principal investigator, Jorge Duconge, University of Puerto Rico
- Investigators
- Giselle T Rivera-Miranda, PharmD, Principal investigator, VACHS at San JuanJorge Duconge, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318057
- Sponsor's protocol ID
- 1SC2HL110393-01A2
- Other IDs
- SC2HL110393
- Status last verified
- Jan 2015
- First submitted
- 17 Mar 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Villagra D, Duconge J, Windemuth A, Cadilla CL, Kocherla M, Gorowski K, Bogaard K, Renta JY, Cruz IA, Mirabal S, Seip RL, Ruano G. CYP2C9 and VKORC1 genotypes in Puerto Ricans: A case for admixture-matching in clinical pharmacogenetic studies. Clin Chim Acta. 2010 Sep 6;411(17-18):1306-11. doi: 10.1016/j.cca.2010.05.021. Epub 2010 May 19.
PubMed 20488169Seip RL, Duconge J, Ruano G. Implementing genotype-guided antithrombotic therapy. Future Cardiol. 2010 May;6(3):409-24. doi: 10.2217/fca.10.6.
PubMed 20462345Duconge J, Cadilla CL, Windemuth A, Kocherla M, Gorowski K, Seip RL, Bogaard K, Renta JY, Piovanetti P, D'Agostino D, Santiago-Borrero PJ, Ruano G. For the patient. DNA makeup of Hispanic persons should be determined before warfarin prescription. Ethn Dis. 2009 Autumn;19(4):479-80. No abstract available.
PubMed 20077595Duconge J, Cadilla CL, Windemuth A, Kocherla M, Gorowski K, Seip RL, Bogaard K, Renta JY, Piovanetti P, D'Agostino D, Santiago-Borrero PJ, Ruano G. Prevalence of combinatorial CYP2C9 and VKORC1 genotypes in Puerto Ricans: implications for warfarin management in Hispanics. Ethn Dis. 2009 Autumn;19(4):390-5.
PubMed 20073138Ruano G, Duconge J, Windemuth A, Cadilla CL, Kocherla M, Villagra D, Renta J, Holford T, Santiago-Borrero PJ. Physiogenomic analysis of the Puerto Rican population. Pharmacogenomics. 2009 Apr;10(4):565-77. doi: 10.2217/pgs.09.5.
PubMed 19374515Rodriguez-Velez R, Ortiz-Rivera OJ, Bower B, Gorowski K, Windemuth A, Villagra D, Kocherla M, Seip RL, D'Agostino D, Vergara C, Ruano G, Duconge J. Exposure to non-therapeutic INR in a high risk cardiovascular patient: potential hazard reduction with genotype-guided warfarin (Coumadin) dosing. P R Health Sci J. 2010 Dec;29(4):402-8.
PubMed 21261182Duconge J, Ruano G. The Emerging Role of Admixture in the Pharmacogenetics of Puerto Rican Hispanics. J Pharmacogenomics Pharmacoproteomics. 2010 Oct 4;1(101):1000101. doi: 10.4172/2153-0645.1000101.
PubMed 23227441Duconge J, Cadilla CL. CYP2D6's functional status associated with the length of hospitalization stay in psychiatric patients: a twist in the tale or evidence that matters? Biomark Med. 2013 Dec;7(6):913-4. doi: 10.2217/bmm.13.109. No abstract available.
PubMed 24266824Ramos AS, Seip RL, Rivera-Miranda G, Felici-Giovanini ME, Garcia-Berdecia R, Alejandro-Cowan Y, Kocherla M, Cruz I, Feliu JF, Cadilla CL, Renta JY, Gorowski K, Vergara C, Ruano G, Duconge J. Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients. Pharmacogenomics. 2012 Dec;13(16):1937-50. doi: 10.2217/pgs.12.171.
PubMed 23215886Valentin II, Vazquez J, Rivera-Miranda G, Seip RL, Velez M, Kocherla M, Bogaard K, Cruz-Gonzalez I, Cadilla CL, Renta JY, Feliu JF, Ramos AS, Alejandro-Cowan Y, Gorowski K, Ruano G, Duconge J. Prediction of warfarin dose reductions in Puerto Rican patients, based on combinatorial CYP2C9 and VKORC1 genotypes. Ann Pharmacother. 2012 Feb;46(2):208-18. doi: 10.1345/aph.1Q190. Epub 2012 Jan 24.
PubMed 22274142Orengo-Mercado C, Nieves B, Lopez L, Valles-Ortiz N, Renta JY, Santiago-Borrero PJ, Cadilla CL, Duconge J. Frequencies of Functional Polymorphisms in Three Pharmacokinetic Genes of Clinical Interest within the Admixed Puerto Rican Population. J Pharmacogenomics Pharmacoproteomics. 2013 Mar 27;4(113):1000113. doi: 10.4172/2153-0645.1000113.
PubMed 24040574Valentin II, Rivera G, Nieves-Plaza M, Cruz I, Renta JY, Cadilla CL, Feliu JF, Seip RL, Ruano G, Duconge J. Pharmacogenetic association study of warfarin safety endpoints in Puerto Ricans. P R Health Sci J. 2014 Sep;33(3):97-104.
PubMed 25244877Duconge J, Ramos AS, Claudio-Campos K, Rivera-Miranda G, Bermudez-Bosch L, Renta JY, Cadilla CL, Cruz I, Feliu JF, Vergara C, Ruano G. A Novel Admixture-Based Pharmacogenetic Approach to Refine Warfarin Dosing in Caribbean Hispanics. PLoS One. 2016 Jan 8;11(1):e0145480. doi: 10.1371/journal.pone.0145480. eCollection 2016.
PubMed 26745506
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of Warfarin in Puerto Rican Patients Using a Physiogenomics Approach.
- ClinicalTrials.gov ID
- NCT01318057
- Acronym / sponsor ID
- 1SC2HL110393-01A2
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Cardiac Valvular Insufficiency, Antiphospholipid Syndrome, Coagulopathy
- Keywords
- Pharmacogenetics, Warfarin, Personalized Medicine, Puerto Ricans, Physiogenomics, Hispanics, Anticoagulants, Cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Hartford Hospital, VA Caribbean Healthcare System
- Study start
- Feb 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Warfarin (Coumadin) is a prescribed "blood thinner" medication used to make the blood less thick in people with high risk of forming blood clots. Despite the various methods to monitor this drug, life-threatening bleeding is a common undesired effect and might result in patient death. Patients starting warfarin therapy may require several weeks or even months to reach the appropriate blood level of warfarin. This blind practice could place the patient at high risk. There are several demographic and clinical factors that significantly influence how much warfarin the patient needs to attain the desired response. Genes, which control hereditary traits, are also important. Now, the investigators know that by using the information encoded in patient's genes the investigators are able to individualize the therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1). This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the investigators are able to determine the structure of the Puerto Rican population in terms of ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1 variants. Secondly, the investigators will assess the association of these variants to clinical responses in order to develop a better method of dose estimation. The expected result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill a gap in the knowledge of warfarin pharmacogenetics, providing new information on the prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as well as their role in the warfarin response variability observed in this admixed population.
Detailed description
Warfarin is a frequently prescribed drug for both the treatment and prevention of thromboembolic complications. Although many reports have been published over the past years in different populations worldwide, there is a fundamental gap in understanding whether variations in CYP2C9 and VKORC1 genes account for the inter-individual variability in response to warfarin that is observed in Puerto Rican patients. This study is a first step toward the development of DNA-driven personalized guidelines for warfarin dose optimization in Puerto Rican patients with thromboembolic complications. Guided by strong preliminary data, this application will pursuit two specific aims: 1) Develop a physiogenomic (PG)-driven admixture analysis of 350 samples from a population of warfarin-treated Puerto Rican patients using the PG array in order to study the pharmacogenetics of warfarin in Puerto Ricans and 2) Determine whether combinatorial CYP2C9 and VKORC1 genotypes are associated with clinical phenotypes during warfarin therapy in Puerto Rican patients. Under the first aim, 350 DNA specimens from warfarin-treated Puerto Rican patients who consent to participate in this study will be genotyped at large-scale using a novel Illumina-based PG-array of 222 candidate genes from relevant cardio-metabolic and neuro-endocrine pathways in order to examine the population structure of Puerto Ricans and create a reference database of individual admixture, allele frequencies, linkage disequilibrium (LD) and haplotypes for pharmacogenetics studies. Noteworthy, this information remains to be determined in Puerto Ricans. Under the second aim, demographic and clinically relevant non-genetic data will be retrospectively collected from medical records of these patients in order to perform an association analysis between their previously obtained CYP2C9 and VKORC1 genotypes and the corresponding time to achieve stable warfarin dosing following survival analysis techniques and Cox proportional hazards model. Accomplishment of this specific aim will also give the basis for developing a DNA-guided warfarin dosing algorithm in Puerto Rican by using these patients as a learning sample. The long-term goal is to generate valuable information from the genetic background of Puerto Ricans in order to further validate the pharmacogenetic-driven warfarin dosing algorithm for this admixed population. The proposed research is significant because it is expected to advance and expand understanding of how these clinically relevant variants affect the way people from an admixed, under-served population respond to warfarin. This is an important and under-investigated area of pharmacogenetics in minority populations that will have potential applicability to personalize warfarin therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wild-Type | – | –Wild-Type are those individuals who were non-carriers of any functional (loss-of-function)variant in CYP2C9 and/or VKORC1 genes |
| Carriers | – | –Those patients who were identified as having any functional CYP2C9 and/or VKORC1 polymorphism |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic Puerto Rican patients from all geographic regions of the Island of Puerto Rico who are currently receiving a standard stable dose of warfarin at the anticoagulation clinic of the Veteran Affair Caribbean Healthcare System (VACHS)
Key inclusion criteria (7 listed)
- Patients whose parents are both Puerto Ricans; male and female aged > 18 years old
- Scheduled to receive the standard 5 mg/day oral dose of warfarin for therapeutic anti-coagulation in indications such as deep vein thrombosis (DVT) with or without Pulmonary Embolism (PE)
- Atrial fibrillation (AF) or other arrhythmias, cardiac valvular replacement, and previously diagnosed coagulopathy
- Hematocrit (Hct) > 40%
- Blood Urea Nitrogen (BUN)/creatinine < 30/1.5 mg/dL
Key exclusion criteria (13 listed)
- Patients currently enrolled in another active research protocol at the Veteran Affairs Caribbean Healthcare System (VACHS) Hospital
- Blood Urea Nitrogen (BUN)/creatinine > 30/2.0 mg/dL
- Active hepatic disease (defined by a Child-Pugh score above 10 points)
- Ascites
- Total bilirubin above 2.0 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to achieve stable warfarin dose
Time frame: 6 months
time to get a stable warfarin dose is defined by the time span (days) from the initial dose until achieving three consecutive INR measurements within therapeutic range (2-3 or 2.5-3.5, according to indication.
2 secondary outcomes
time to first bleeding
Time frame: 6 months
time to first INR>4
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Background: PubMed 20488169Villagra D, Duconge J, Windemuth A, Cadilla CL, Kocherla M, Gorowski K, Bogaard K, Renta JY, Cruz IA, Mirabal S, Seip RL, Ruano G. CYP2C9 and VKORC1 genotypes in Puerto Ricans: A case for admixture-matching in clinical pharmacogenetic studies. Clin Chim Acta. 2010 Sep 6;411(17-18):1306-11. doi: 10.1016/j.cca.2010.05.021. Epub 2010 May 19.
- Background: PubMed 20462345Seip RL, Duconge J, Ruano G. Implementing genotype-guided antithrombotic therapy. Future Cardiol. 2010 May;6(3):409-24. doi: 10.2217/fca.10.6.
- Background: PubMed 20077595Duconge J, Cadilla CL, Windemuth A, Kocherla M, Gorowski K, Seip RL, Bogaard K, Renta JY, Piovanetti P, D'Agostino D, Santiago-Borrero PJ, Ruano G. For the patient. DNA makeup of Hispanic persons should be determined before warfarin prescription. Ethn Dis. 2009 Autumn;19(4):479-80. No abstract available.
- Background: PubMed 20073138Duconge J, Cadilla CL, Windemuth A, Kocherla M, Gorowski K, Seip RL, Bogaard K, Renta JY, Piovanetti P, D'Agostino D, Santiago-Borrero PJ, Ruano G. Prevalence of combinatorial CYP2C9 and VKORC1 genotypes in Puerto Ricans: implications for warfarin management in Hispanics. Ethn Dis. 2009 Autumn;19(4):390-5.
- Background: PubMed 19374515Ruano G, Duconge J, Windemuth A, Cadilla CL, Kocherla M, Villagra D, Renta J, Holford T, Santiago-Borrero PJ. Physiogenomic analysis of the Puerto Rican population. Pharmacogenomics. 2009 Apr;10(4):565-77. doi: 10.2217/pgs.09.5.
- Background: PubMed 21261182Rodriguez-Velez R, Ortiz-Rivera OJ, Bower B, Gorowski K, Windemuth A, Villagra D, Kocherla M, Seip RL, D'Agostino D, Vergara C, Ruano G, Duconge J. Exposure to non-therapeutic INR in a high risk cardiovascular patient: potential hazard reduction with genotype-guided warfarin (Coumadin) dosing. P R Health Sci J. 2010 Dec;29(4):402-8.
- Background: PubMed 23227441Duconge J, Ruano G. The Emerging Role of Admixture in the Pharmacogenetics of Puerto Rican Hispanics. J Pharmacogenomics Pharmacoproteomics. 2010 Oct 4;1(101):1000101. doi: 10.4172/2153-0645.1000101.
- Background: PubMed 24266824Duconge J, Cadilla CL. CYP2D6's functional status associated with the length of hospitalization stay in psychiatric patients: a twist in the tale or evidence that matters? Biomark Med. 2013 Dec;7(6):913-4. doi: 10.2217/bmm.13.109. No abstract available.
- Results publication: PubMed 23215886Ramos AS, Seip RL, Rivera-Miranda G, Felici-Giovanini ME, Garcia-Berdecia R, Alejandro-Cowan Y, Kocherla M, Cruz I, Feliu JF, Cadilla CL, Renta JY, Gorowski K, Vergara C, Ruano G, Duconge J. Development of a pharmacogenetic-guided warfarin dosing algorithm for Puerto Rican patients. Pharmacogenomics. 2012 Dec;13(16):1937-50. doi: 10.2217/pgs.12.171.
- Results publication: PubMed 22274142Valentin II, Vazquez J, Rivera-Miranda G, Seip RL, Velez M, Kocherla M, Bogaard K, Cruz-Gonzalez I, Cadilla CL, Renta JY, Feliu JF, Ramos AS, Alejandro-Cowan Y, Gorowski K, Ruano G, Duconge J. Prediction of warfarin dose reductions in Puerto Rican patients, based on combinatorial CYP2C9 and VKORC1 genotypes. Ann Pharmacother. 2012 Feb;46(2):208-18. doi: 10.1345/aph.1Q190. Epub 2012 Jan 24.
- Results publication: PubMed 24040574Orengo-Mercado C, Nieves B, Lopez L, Valles-Ortiz N, Renta JY, Santiago-Borrero PJ, Cadilla CL, Duconge J. Frequencies of Functional Polymorphisms in Three Pharmacokinetic Genes of Clinical Interest within the Admixed Puerto Rican Population. J Pharmacogenomics Pharmacoproteomics. 2013 Mar 27;4(113):1000113. doi: 10.4172/2153-0645.1000113.
- Results publication: PubMed 25244877Valentin II, Rivera G, Nieves-Plaza M, Cruz I, Renta JY, Cadilla CL, Feliu JF, Seip RL, Ruano G, Duconge J. Pharmacogenetic association study of warfarin safety endpoints in Puerto Ricans. P R Health Sci J. 2014 Sep;33(3):97-104.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giselle T Rivera-Miranda, PharmD principal investigator
VACHS at San Juan
Jorge Duconge, PhD principal investigator
University of Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by University of Puerto Rico at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to achieve stable warfarin dose (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318057, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.