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NCT05609500
Warfarin Dosage Adjustment Model Analysis Study
trial testing Warfarin dosage adjustment model in Warfarin in 1,200 participants. Status unknown.
6 September 2023
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 6 September 2022 |
| Primary completion | 6 September 2023 |
| Estimated completion | 23 December 2023 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- Warfarin dosage adjustment model
Conditions studied
- Warfarin — all drugs for Warfarin →
Sponsor
Chinese University of Hong Kong
Who can join
Eligibility, any sex, with Warfarin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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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 NCT05609500 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 8 November 2022
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