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Trial record 5 of 293 for:    warfarin AND anticoagulation

Warfarin Anticoagulation in Patients in Sub-Saharan Africa (War-PATH)

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ClinicalTrials.gov Identifier: NCT03512080
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Sir Munir Pirmohamed, University of Liverpool

Tracking Information
First Submitted Date February 18, 2018
First Posted Date April 30, 2018
Last Update Posted Date October 12, 2018
Actual Study Start Date June 11, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2018)
  • Identification of demographic, clinical and genetic factors in an African population that determine daily warfarin dosing requirements [ Time Frame: 1 year ]
    Completion of an audit to evaluate the current quality of anticoagulant services in Cape Town and rural and urban Uganda taking into account the indications, anticoagulant clinic set-up and quality of anticoagulation control.
  • Development of a clinical algorithm taking into account patient factors, co-medications and underlying disease [ Time Frame: 3 years ]
    Recruitment of patients currently on warfarin will be undertaken to identify clinical and other non-genetic factors associated with poor anticoagulation control to enable development of a warfarin clinical dosing algorithm. Data on patients' age, weight, height, gender, co-morbidities, co-medications, socio-economic factors, warfarin dose history and quality of anticoagulant control (International Normalised ratio (INR) measurement history) will be obtained for the algorithm development.
  • Development of a validated warfarin dosing algorithm taking into account both clinical and genetic factors [ Time Frame: 3+ years ]
    Evaluation of genes specific to the local African populations in Uganda and South Africa that can impact on anticoagulation control will be carried out, resulting in the development of a novel genetic dosing algorithm. In order to identify ethnic specific genetic factors, the investigators will undertake a Genome-wide Association Study (GWAS) on these patients, and any novel genetic factors will be incorporated into an improved dosing algorithm which will be compared with the original algorithm in terms of its ability to predict therapeutic dose.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03512080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Warfarin Anticoagulation in Patients in Sub-Saharan Africa
Official Title National Institute of Health Research (NIHR) Global Health Research Group on Warfarin Anticoagulation in Patients With Cardiovascular Disease in Sub-Saharan Africa
Brief Summary

This research programme aims to translate expertise in warfarin anticoagulation from resource-rich to low and middle income countries (LMIC)settings with the goal of improving patient health outcomes.

An observational study which will be used to develop warfarin dosing algorithms - the ultimate aim will be to ascertain whether these algorithms increase time in the therapeutic range, reduce bleeding and thrombotic risks, and clinic visits for International Normalised ratio (INR) monitoring. Two algorithms will be developed: the first will take into account clinical and geographical factors ("clinical algorithm"), while the second will also incorporate genetic factors in addition to the clinical and geographical factors ("genetic algorithm"). Patients will be recruited from sites in rural and urban Uganda, and in Cape Town, South Africa, to develop a clinical dosing algorithm. It is important to note that there is a wealth of literature data which will be used to define the clinical data that needs to be collected from these patients. To identify genetic factors in African patients, Genome-wide Association Study (GWAS) will be undertaken and any novel factors incorporated into the genetic algorithm - the percentage variation in warfarin dosing explained by the genetic algorithm will be compared with the clinical algorithm.

Detailed Description

This project focuses on an area unmet clinical need, oral anticoagulation, in patients with a variety of cardiovascular diseases. The investigators' ambition is to translate their internationally renowned expertise in warfarin anticoagulation into low and middle income country (LMIC) settings where it can significantly improve health. By working with policy makers, the investigators will provide the required evidence to allow national roll out of new practices, including the introduction of 1mg warfarin tablets as a quick win to improve dosing accuracy.

This National Institute of Health Research (NIHR) Global Research Group is a collaboration between the University of Liverpool and two low and middle income countries (LMICs), Uganda and South Africa. It will focus on a clinically important non-communicable disease area which requires the use of anticoagulation.

Anticoagulants, in particular warfarin, are used in these countries for the treatment of venous thromboembolism, valvular heart disease including rheumatic heart disease and prevention of strokes in patients with irregular heart rhythms (atrial fibrillation). Anticoagulation represents an unmet clinical need in Sub-Saharan Africa as patients either do not receive anticoagulation (because of difficulties in monitoring) or are poorly anticoagulated because of poor dosing guidelines. This results in potentially preventable morbidity and mortality which affects the poorer sectors of the population in particular. The investigators have extensive expertise in the United Kingdom and European Union of improving the use of warfarin through the development of novel dosing algorithms, which have now begun incorporating genetic factors.

By contrast, in the investigators' two collaborating partner countries, no locally validated warfarin dosing algorithms exist, even those which only take into account clinical factors. This results in haphazard dosing with the attendant risks of thrombotic or bleeding complications. In both countries, monitoring requires frequent clinic visits, incurring transport costs and missed work days. Patients are often co-infected with human immunodeficiency virus (HIV) and/or Tuberculosis, requiring multiple concomitant medicines which complicate warfarin dosing and dose adjustment.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Self-reported Black African ethnicity from Uganda and South Africa
Condition Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts Stable International Normalised Ratio
Consenting adult patients with either venous thromboembolism (VTE), atrial fibrillation (AF) on warfarin with a target International Normalised Ratio (INR) (INR range 2-3) or valvular heart disease with a target INR (INR range 3-4).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2018)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2020
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Consenting adult patients with either venous thromboembolism (VTE), atrial fibrillation (AF) on warfarin with a target International Normalised Ratio (INR) (INR range 2-3) or valvular heart disease with a target INR (INR range 3-4).
  2. On a stable maintenance dose for two consecutive clinic visits within the last six months, and the INR was in the therapeutic range at each of those visits.
  3. Age over 18 years.
  4. Self-reported Black African ethnicity.
  5. Signed or witnessed written (witnessed thumbprint for illiterate participants) informed consent.

Exclusion Criteria:

  1. Patient unwilling to take part.
  2. Patient is, in the opinion of the investigator, not suitable to participate.
  3. Pregnant women.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Claire Hutchinson 44 151 794 5791 chutch@liverpool.ac.uk
Listed Location Countries South Africa,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number NCT03512080
Other Study ID Numbers UoL001324
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Professor Sir Munir Pirmohamed, University of Liverpool
Study Sponsor University of Liverpool
Collaborators Not Provided
Investigators
Principal Investigator: Munir Pirmohamed University of Liverpool
PRS Account University of Liverpool
Verification Date October 2018