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NCT04062097: RIC-ICH
Registration of Idarucizumab for Patients with IntraCranial Hemorrhage
trial testing Dabigatran Etexilate Oral Capsule [Pradaxa] in Intracranial Hemorrhage in 104 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | University Hospital, Essen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 104 |
| Start date | 19 September 2019 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 33 locations across Germany |
Drugs / interventions tested
- Dabigatran Etexilate Oral Capsule [Pradaxa] — full drug profile →
- Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND] — full drug profile →
- Vitamin K antagonist — full drug profile →
Conditions studied
- Intracranial Hemorrhage — all drugs for Intracranial Hemorrhage →
Sponsor
University Hospital, Essen
Who can join
18 and older, any sex, with Intracranial Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in Therapeutic Approaches for Spontaneous Intracerebral Hemorrhage.
Al-Kawaz MN, Hanley DF, Ziai W. · · 2020 · cited 79× · PMID 32720246 · DOI 10.1007/s13311-020-00902-w -
Outcome after intracranial hemorrhage under dabigatran and reversal with idarucizumab versus under vitamin-K-antagonists - the RIC-ICH study.
Kuklik N, Hüsing A, Stang A, Brinkmann M, et al · · 2023 · cited 3× · PMID 37554390 · DOI 10.3389/fneur.2023.1212495
Verify or expand the search:
- PubMed search for NCT04062097
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Intracranial Hemorrhage
Currently open trials in the same condition.
- NCT07088250 — Statins for Treatment of Primary Intracerebral Hemorrhage · NA · recruiting
- NCT05361070 — Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy · active not recruiting
Other University Hospital, Essen trials
Trials by the same sponsor.
- NCT07409584 — Mental Health and Suicidality in Glioblastoma Patients in Germany · recruiting
- NCT07359690 — Multimodal Analysis of Endomyocardial Biopsies · recruiting
- NCT06388369 — Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer · Phase 1, PHASE2 · terminated
- NCT07130526 — Distrupt Stiffness Trial · NA · recruiting
- NCT07343466 — Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation · recruiting
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 NCT04062097 (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 University Hospital, Essen
- Last refreshed: 9 December 2024
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/NCT04062097.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing