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NCT00182104
An International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures
Phase 4 trial testing Warfarin vs ASA in Heart Defect in 111 participants. Completed in 1 July 2005.
Quick facts
| Lead sponsor | Hamilton Health Sciences Corporation |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 111 |
| Start date | 1 August 1998 |
| Estimated completion | 1 July 2005 |
| Sites | 7 locations across Australia, Canada |
Drugs / interventions tested
- Warfarin vs ASA — full drug profile →
Conditions studied
- Heart Defect — all drugs for Heart Defect →
- Triscupid Atresia — all drugs for Triscupid Atresia →
Sponsor
Hamilton Health Sciences Corporation — full company profile →
Who can join
Eligibility, any sex, with Heart Defect or Triscupid Atresia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Warfarin vs ASA in prevention of thrombosis 2 yrs after Fontan
Sponsor's own description
Compare heparin/warfarin to ASA for thromboembolic prophylaxis in the first two years following Fontan procedures.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children.
Monagle P, Cochrane A, Roberts R, Manlhiot C, et al · · 2011 · cited 160× · PMID 21798429 · DOI 10.1016/j.jacc.2011.01.061
Verify or expand the search:
- PubMed search for NCT00182104
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hamilton Health Sciences Corporation trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00182104 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hamilton Health Sciences Corporation
- Last refreshed: 19 April 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00182104.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing