Heart DefectPhase 4NCT00182104
International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
A Phase 4 study testing Warfarin vs ASA in people with Heart Defect and Triscupid Atresia, run by Hamilton Health Sciences Corporation at 7 sites in 2 countries.
Trial summary
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Defect, Triscupid Atresia
- What is being tested?
- Warfarin vs ASA
- How many people
- 111 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 1998to Jul 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patient is scheduled to have a Fontan or modified Fontan procedure
Who cannot join
- Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
- Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
- Inability to supervise therapy due to social or geographical reasons.
- Pregnancy or potential pregnancy during study period
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
University of Alberta HSC
Edmonton, Alberta, T6G 2R7
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Hopital Ste-Justine
Montreal, Quebec, H3T 1C5
Sick Children's Hospital
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
- Conditions
- Heart Defect, Triscupid Atresia
- Being tested
- Warfarin vs ASA
- Keywords
- Fontan procedure, Anticoagulation, Thrombosis, Thromboembolism, Prevention
- Medical subject headings
- Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin vs ASADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Secondary outcomes (2)
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 1998
- Study completionJul 2005
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 Heart DefectStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Paul Monagle, MD, Study chair, Royal Children's Hospital, Parkville, Victoria, AustraliaBrian McCrindle, MD, Principal investigator, The Hospital for Sick ChildrenRobin Roberts, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182104
- Sponsor's protocol ID
- CTMG-1998-Fontan
- Other IDs
- Hearth and Stroke grant 1998
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
Publications
McCrindle BW, Manlhiot C, Cochrane A, Roberts R, Hughes M, Szechtman B, Weintraub R, Andrew M, Monagle P; Fontan Anticoagulation Study Group. Factors associated with thrombotic complications after the Fontan procedure: a secondary analysis of a multicenter, randomized trial of primary thromboprophylaxis for 2 years after the Fontan procedure. J Am Coll Cardiol. 2013 Jan 22;61(3):346-53. doi: 10.1016/j.jacc.2012.08.1023. Epub 2012 Dec 12.
PubMed 23246393Monagle P, Cochrane A, Roberts R, Manlhiot C, Weintraub R, Szechtman B, Hughes M, Andrew M, McCrindle BW; Fontan Anticoagulation Study Group. A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. J Am Coll Cardiol. 2011 Aug 2;58(6):645-51. doi: 10.1016/j.jacc.2011.01.061.
PubMed 21798429
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
- ClinicalTrials.gov ID
- NCT00182104
- Acronym / sponsor ID
- CTMG-1998-Fontan
- Conditions
- Heart Defect, Triscupid Atresia
- Keywords
- Fontan procedure, Anticoagulation, Thrombosis, Thromboembolism, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Aug 1998
- Study completion
- Jul 2005 (actual)
- First posted
- 16 Sep 2005 (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.
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patient is scheduled to have a Fontan or modified Fontan procedure
Key exclusion criteria (4 listed)
- Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
- Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
- Inability to supervise therapy due to social or geographical reasons.
- Pregnancy or potential pregnancy during 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 |
|---|---|---|
| Warfarin vs ASA | Drug | – |
Primary outcome
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
2 secondary outcomes
Identify subpopulation of Fontan pts at high risk for TEs
Determine high risk period for TEs in first 2 yrs post Fontan
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 Apr 2007.
- Derived from this study: PubMed 23246393McCrindle BW, Manlhiot C, Cochrane A, Roberts R, Hughes M, Szechtman B, Weintraub R, Andrew M, Monagle P; Fontan Anticoagulation Study Group. Factors associated with thrombotic complications after the Fontan procedure: a secondary analysis of a multicenter, randomized trial of primary thromboprophylaxis for 2 years after the Fontan procedure. J Am Coll Cardiol. 2013 Jan 22;61(3):346-53. doi: 10.1016/j.jacc.2012.08.1023. Epub 2012 Dec 12.
- Derived from this study: PubMed 21798429Monagle P, Cochrane A, Roberts R, Manlhiot C, Weintraub R, Szechtman B, Hughes M, Andrew M, McCrindle BW; Fontan Anticoagulation Study Group. A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. J Am Coll Cardiol. 2011 Aug 2;58(6):645-51. doi: 10.1016/j.jacc.2011.01.061.
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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.
Paul Monagle, MD study chair
Royal Children's Hospital, Parkville, Victoria, Australia
Brian McCrindle, MD principal investigator
The Hospital for Sick Children
Robin Roberts, MD principal investigator
McMaster University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin vs ASA in people with Heart Defect and Triscupid Atresia, run by Hamilton Health Sciences Corporation at 7 sites in 2 countries.
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 4 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 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Australia. 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?
Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan. 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 NCT00182104, 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 20 Apr 2007.