CardiopathyPhase 4NCT01006486
Outcomes of an Anticoagulation Clinic in an University Hospital
A Phase 4 study testing Anticoagulation clinic and Standard anticoagulation care in people with Cardiopathy and Chagas Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopathy, Chagas Disease, Hemorrhage
- What is being tested?
- Anticoagulation clinic and Standard anticoagulation care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Aug 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Outpatients
- Chagas and non-Chagas disease patients
- Any indication for chronic treatment with warfarin
- Anticoagulation for at least 30 days.
Who cannot join
- Refusal to participate in the study;
- Use of phenprocoumon;
- Expectation of treatment lower than 1 year;
- Difficulties to attend medical visits;
- Participation in other prospective clinical study involving anticoagulation care during the study period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
About this study
Official title: Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil
A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.
Read the detailed description
A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.
- Conditions
- Cardiopathy, Chagas Disease, Hemorrhage, Thrombosis
- Being tested
- Anticoagulation clinic, Standard anticoagulation care
- Keywords
- Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage
- Medical subject headings
- Heart Diseases, Chagas Disease, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation clinicOther
Also called Implementation of a health service
Patients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins.
Standard anticoagulation careOther
Also called Implementation of a health service
Patients randomized to this arm will be cared by their physician, with standard care. No standardized protocol of the use of coumarins will be established.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation clinic | Experimental | Anticoagulation clinic, including all procedures related to a standardized use of coumarins. Receives: Other: Anticoagulation clinic |
| Standard care | Active comparator | Standard use of coumarins, as prescribed by their physicians. Receives: Other: Standard anticoagulation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range
Measured: 1 year
Secondary outcomes (2)
Hemorrhagic events
Measured: 1 year
Thromboembolic events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiopathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais
- Investigators
- Antonio L Ribeiro, MD, PhD, Study chair, Federal University of Minas GeraisManoel Otávio C Rocha, MD, PhD, Principal investigator, Federal University of Minas GeraisMaria Auxiliadora P Martins, Pharmacist, Principal investigator, Federal University of Minas GeraisCibele C César, MD, PhD, Principal investigator, Federal University of Minas GeraisDaniel D Ribeiro, Physician, Principal investigator, Federal University of Minas GeraisVandack Nobre, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006486
- Sponsor's protocol ID
- COEP376/09
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 2009
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Impact of the Implantation of an Anticoagulation Clinic in an University Hospital in Brazil
- ClinicalTrials.gov ID
- NCT01006486
- Acronym / sponsor ID
- COEP376/09
- Conditions
- Cardiopathy, Chagas Disease, Hemorrhage, Thrombosis
- Keywords
- Oral anticoagulants, Warfarin, Anticoagulation clinic, Thrombosis, Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Nov 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.
A clinical trial designed to compare the oral anticoagulation control obtained by an anticoagulation clinic and the usual medical care in Chagas and Non-Chagas disease patients.
Detailed description
A Randomized, Crossover, Clinical Trial performed to compare the results of oral anticoagulation for Chagas and non-Chagas disease patients treated at an anticoagulation clinic and by the usual clinical practice. The primary endpoint was the time that the International Normalized Ratio (INR) was in the therapeutic range and the secondary endpoints were thromboembolic/haemorragic events.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation clinic | Experimental | Other: Anticoagulation clinicAnticoagulation clinic, including all procedures related to a standardized use of coumarins. |
| Standard care | Active comparator | Other: Standard anticoagulation careStandard use of coumarins, as prescribed by their physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients
- Chagas and non-Chagas disease patients
- Any indication for chronic treatment with warfarin
- Anticoagulation for at least 30 days.
Key exclusion criteria (5 listed)
- Refusal to participate in the study;
- Use of phenprocoumon;
- Expectation of treatment lower than 1 year;
- Difficulties to attend medical visits;
- Participation in other prospective clinical study involving anticoagulation care during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation clinicAlso: Implementation of a health servicePatients randomized to this arm will be cared at an anticoagulation clinic, with educational measures and standardized procedures related to the use of coumarins. | Other | Anticoagulation clinic |
| Standard anticoagulation careAlso: Implementation of a health servicePatients randomized to this arm will be cared by their physician, with standard care. No standardized protocol of the use of coumarins will be established. | Other | Standard care |
Primary outcome
Time in therapeutic range
Time frame: 1 year
2 secondary outcomes
Hemorrhagic events
Time frame: 1 year
Thromboembolic events
Time frame: 1 year
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 25 Oct 2011.
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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.
Antonio L Ribeiro, MD, PhD study chair
Federal University of Minas Gerais
Manoel Otávio C Rocha, MD, PhD principal investigator
Federal University of Minas Gerais
Maria Auxiliadora P Martins, Pharmacist principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticoagulation clinic and Standard anticoagulation care in people with Cardiopathy and Chagas Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 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 25 Oct 2011. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in therapeutic range (time frame: 1 year). 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 25 Oct 2011.