Cardiac PacingNCT00621491
Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation
A study testing Warfarin in people with Cardiac Pacing and Complications, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Pacing, Complications, Venous Thrombosis
- What is being tested?
- Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2004to Jul 2008
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices
- left ventricular ejection fraction ≤0.40 and/or
- previous transvenous temporary leads ipsilateral to the permanent device implant
Who cannot join
- history of venous thromboembolism
- atrial fibrillation
- coagulopathy or platelet disorder
- malignancy
- gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months
- abnormal prothrombin time (PT)or an international normalized ratio (INR) >40%, or treated with oral anticoagulants
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-900
About this study
Official title: Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients
The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.
Read the detailed description
Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography.
- Conditions
- Cardiac Pacing, Complications, Venous Thrombosis
- Being tested
- Warfarin
- Keywords
- cardiac pacing, pacing complication, venous thrombosis, warfarin, anticoagulation, randomized trial
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called oral anticoagulants
Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Single daily dose of Placebo during six months Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of venous obstructions observed by digital subtraction venography
Measured: Six months
Secondary outcomes (1)
Safety of anticoagulant therapy, morbidity and overall mortality
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2004
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac PacingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Roberto Costa, University of Sao Paulo
- Investigators
- Roberto Costa, MD PhD, Study chair, University of Sao PauloKatia R Silva, RN PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621491
- Sponsor's protocol ID
- SDC 2273/03/067
- Status last verified
- Jan 2008
- First submitted
- 11 Feb 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Costa R, Da Silva KR, Rached R, Martinelli Filho M, Carnevale FC, Moreira LF, Stolf NA. Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.
PubMed 19250106Silva KR, Costa R, Abi Rached R, Martinelli Filho M, Caldas JG, Carnevale FC, Moreira LF, Stolf NA. Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis. Rev Bras Cir Cardiovasc. 2008 Oct-Dec;23(4):542-9. doi: 10.1590/s0102-76382008000400015. English, Portuguese.
PubMed 19229428
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients
- ClinicalTrials.gov ID
- NCT00621491
- Acronym / sponsor ID
- SDC 2273/03/067
- Conditions
- Cardiac Pacing, Complications, Venous Thrombosis
- Keywords
- cardiac pacing, pacing complication, venous thrombosis, warfarin, anticoagulation, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Feb 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Feb 2008 (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 aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.
Detailed description
Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: WarfarinSingle daily dose of Placebo during six months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices
- left ventricular ejection fraction ≤0.40 and/or
- previous transvenous temporary leads ipsilateral to the permanent device implant
Key exclusion criteria (6 listed)
- history of venous thromboembolism
- atrial fibrillation
- coagulopathy or platelet disorder
- malignancy
- gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months
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 |
|---|---|---|
| WarfarinAlso: oral anticoagulantsSingle daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months | Drug | 1 |
Primary outcome
Incidence of venous obstructions observed by digital subtraction venography
Time frame: Six months
1 secondary outcome
Safety of anticoagulant therapy, morbidity and overall mortality
Time frame: Six 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 26 Oct 2012.
- Results publication: PubMed 19250106Costa R, Da Silva KR, Rached R, Martinelli Filho M, Carnevale FC, Moreira LF, Stolf NA. Prevention of venous thrombosis by warfarin after permanent transvenous leads implantation in high-risk patients. Pacing Clin Electrophysiol. 2009 Mar;32 Suppl 1:S247-51. doi: 10.1111/j.1540-8159.2008.02295.x.
- Results publication: PubMed 19229428Silva KR, Costa R, Abi Rached R, Martinelli Filho M, Caldas JG, Carnevale FC, Moreira LF, Stolf NA. Warfarin prevents venous obstruction after cardiac devices implantation in high-risk patients: partial analysis. Rev Bras Cir Cardiovasc. 2008 Oct-Dec;23(4):542-9. doi: 10.1590/s0102-76382008000400015. English, Portuguese.
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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.
Roberto Costa, MD PhD study chair
University of Sao Paulo
Katia R Silva, RN PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin in people with Cardiac Pacing and Complications, run by University of Sao Paulo 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 3 inclusion and 6 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 26 Oct 2012. 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. Some participants in this study may receive a placebo. 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?
Incidence of venous obstructions observed by digital subtraction venography (time frame: Six 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 NCT00621491, which also lists 2 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 26 Oct 2012.