Atrial FibrillationNCT00905177
Predictors of Anticoagulation Control on Warfarin Therapy
An observational study of Atrial Fibrillation and Deep Vein Thrombosis, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Vein Thrombosis, Heart Valve Replacement
- How many people
- 687 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Aug 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.
Who may be able to join
- All Caucasians and African Americans who are new to warfarin therapy
Who cannot join
- Under 21 years of age
- Non caucasian
- Non african american
- Have an abnormal INR before warfarin or heparin therapy
- Unable to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania, Anticoagulation Management Center
Philadelphia, Pennsylvania, 19104
Philadelphia Veteran Affairs Medical Center
Philadelphia, Pennsylvania, 19104
About this study
The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.
Read the detailed description
This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.
- Keywords
- Atrial Fibrillation, deep vein thrombosis, anticoagulation, warfarin, coumadin
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stephen E. Kimmel, M.D. MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905177
- Sponsor's protocol ID
- 700902
- Status last verified
- May 2016
- First submitted
- 18 May 2009
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Anticoagulation Control on Warfarin Therapy
- ClinicalTrials.gov ID
- NCT00905177
- Acronym / sponsor ID
- 700902
- Keywords
- Atrial Fibrillation, deep vein thrombosis, anticoagulation, warfarin, coumadin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 May 2009 (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.
The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.
Detailed description
This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include all self-identified Caucasians and African Americans initiating warfarin therapy.
Key inclusion criteria (1 listed)
- All Caucasians and African Americans who are new to warfarin therapy
Key exclusion criteria (5 listed)
- Under 21 years of age
- Non caucasian
- Non african american
- Have an abnormal INR before warfarin or heparin therapy
- Unable to provide consent
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
Not reported in the source record.
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 20 May 2016.
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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.
Stephen E. Kimmel, M.D. MS principal investigator
University of Pennsylvania
2 sites 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 Pennsylvania at 2 sites in United States.
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 1 inclusion and 5 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Where can I read the original study information?
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 20 May 2016.