Anticoagulated PatientsNCT01392040
Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy
An observational study of Anticoagulated Patients, run by University Of Perugia at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulated Patients
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the conditions for the patients inclusion are: to take oral anticoagulant therapy for at least 2 years; to be in stable conditions for at last 3 months
Who may be able to join
- to take oral anticoagulant therapy for at least 2 years
- to be in stable conditions for at last 3 months
Who cannot join
- patients who need to perform surgery
- patients who interrupt therapy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.
- Conditions
- Anticoagulated Patients
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 |
|---|---|---|
| Patients in oral anticoagulant therapy | Patients taking oral anticoagulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in therapeutic range of INR by the patients
Measured: 6 months
Secondary outcomes (1)
Thrombotic and bleeding events
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 posted12 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulated PatientsStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Iorio, University Of Perugia
- Investigators
- Michela Basileo, Dr, Principal investigator, University Of PerugiaAlfonso Iorio, Dr, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392040
- Sponsor's protocol ID
- MIV_AI_10_001
- Status last verified
- Jan 2013
- First submitted
- 11 Jul 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy
- ClinicalTrials.gov ID
- NCT01392040
- Acronym / sponsor ID
- MIV_AI_10_001
- Conditions
- Anticoagulated Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Jul 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.
The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in oral anticoagulant therapy | – | –Patients taking oral anticoagulant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the conditions for the patients inclusion are: to take oral anticoagulant therapy for at least 2 years; to be in stable conditions for at last 3 months
Key inclusion criteria (2 listed)
- to take oral anticoagulant therapy for at least 2 years
- to be in stable conditions for at last 3 months
Key exclusion criteria (2 listed)
- patients who need to perform surgery
- patients who interrupt therapy
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 spent in therapeutic range of INR by the patients
Time frame: 6 months
1 secondary outcome
Thrombotic and bleeding events
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 17 Jan 2013.
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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.
Michela Basileo, Dr principal investigator
University Of Perugia
Alfonso Iorio, Dr principal investigator
McMaster University
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 Anticoagulated Patients, run by University Of Perugia at 1 site in Italy.
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 2 inclusion and 2 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 17 Jan 2013. 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 Italy. 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 spent in therapeutic range of INR by the patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
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 17 Jan 2013.