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NCT03157154: ERHEA
Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
trial testing Non interventional study in Hemophilia in 259 participants. Completed in 30 July 2017.
30 July 2017
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 259 |
| Start date | 27 June 2017 |
| Primary completion | 30 July 2017 |
| Estimated completion | 30 July 2017 |
| Sites | 6 locations across France |
Drugs / interventions tested
- Non interventional study
Conditions studied
- Hemophilia — all drugs for Hemophilia →
Sponsor
Nantes University Hospital
Who can join
50 and older, male only, with Hemophilia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants. The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients. Secondary endpoint consist in: * Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR) * Evaluate the number of sever bleeding event in patient under study treatments compared to the control group * Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group * Estimate the stenosis relapse risk in haemophilia patients with arterial STENT * Estimate the embolic risk of haemophilia patients with atrial fibrillation Population description: Haemophilia patients (man, all severity) Age above 50 years, followed during the last 5 years in one of the study centre
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 NCT03157154
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03157154 (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 Nantes University Hospital
- Last refreshed: 23 January 2020
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/NCT03157154.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing