Last reviewed · How we verify
NCT04532333: BUILD
Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms: an Open-label, Multicenter, Randomized Pilot Study（BUILD）
Phase 3 trial testing Bivalirudin 250 MG Injection in Subarachnoid Hemorrhage, Aneurysmal in 236 participants. Status unknown.
1 May 2021
Quick facts
| Lead sponsor | Changhai Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 236 |
| Start date | 1 August 2020 |
| Primary completion | 1 May 2021 |
| Estimated completion | 1 June 2021 |
Drugs / interventions tested
- Bivalirudin 250 MG Injection — full drug profile →
- Heparin (HEPARIN) — full drug profile →
Conditions studied
- Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
Sponsor
Changhai Hospital
Who can join
Adults 18 to 80, any sex, with Subarachnoid Hemorrhage, Aneurysmal. 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.
-
Procedure-related complication
Time frame: 30 days
A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium
Sponsor's own description
This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms. Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04532333
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal
Currently open trials in the same condition.
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- NCT06819657 — Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid H · NA · recruiting
- NCT06766422 — AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction · recruiting
- NCT06906432 — Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage · recruiting
- NCT06218654 — Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage · recruiting
Other Changhai Hospital trials
Trials by the same sponsor.
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- NCT07507071 — Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions · not yet recruiting
- NCT07481591 — Capsule Endoscopy in GI Bleeding: A Retrospective Study · not yet recruiting
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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 NCT04532333 (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 Changhai Hospital
- Last refreshed: 26 August 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/NCT04532333.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing