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NCT04136379
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
trial testing INR monitoring using a CoaguChek POC device in Congenital Heart Disease in 18 participants. Completed in 31 October 2021.
31 October 2021
Quick facts
| Lead sponsor | University of Ulster |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 18 |
| Start date | 30 September 2019 |
| Primary completion | 31 October 2021 |
| Estimated completion | 31 October 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- INR monitoring using a CoaguChek POC device
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
- Congenital Heart Defect — all drugs for Congenital Heart Defect →
- Adult Congenital Heart Disease — all drugs for Adult Congenital Heart Disease →
Sponsor
University of Ulster
Who can join
14 and older, any sex, with Congenital Heart Disease or Congenital Heart Defect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04136379
- Europe PMC full search
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- bioRxiv preprints
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Other University of Ulster 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 NCT04136379 (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 University of Ulster
- Last refreshed: 3 November 2022
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/NCT04136379.
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