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NCT03720067: Betastatin
Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension
Phase 2, PHASE3 trial testing Propranolol in Cirrhosis in 80 participants. Status unknown.
20 December 2020
Quick facts
| Lead sponsor | Universidade Federal do Rio de Janeiro |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 25 January 2019 |
| Primary completion | 20 December 2020 |
| Estimated completion | 20 December 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Propranolol (propranolol) — full drug profile →
- Carvedilol (CARVEDILOL) — full drug profile →
- Rosuvastatin (rosuvastatin) — full drug profile →
- Placebo
Conditions studied
- Cirrhosis — all drugs for Cirrhosis →
- Portal Hypertension — all drugs for Portal Hypertension →
- Variceal Hemorrhage — all drugs for Variceal Hemorrhage →
Sponsor
Universidade Federal do Rio de Janeiro — full company profile →
Who can join
18 and older, any sex, with Cirrhosis or Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with hepatic cirrhosis and previous variceal bleeding will be randomly assigned to use propranolol or carvedilol. After 8 weeks, rosuvastatin or placebo will be blindly added to nonresponders (HVPG measurement \> 12mmHg) for another 8 weeks and hemodynamic response will be assessed again. Surrogate serum markers of portal hypertension will be evaluated and correlated to HVPG values and to its variations.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advancements in Beta-Adrenergic Therapy and Novel Personalised Approach for Portal Hypertension: A Narrative Review.
Avram RI, Minea HO, Huiban L, Damian IR, et al · · 2025 · cited 1× · PMID 40868821 · DOI 10.3390/life15081173 -
Letter to the editor: Statins in esophageal variceal bleeding: What works in primary prophylaxis should not be presumed for secondary prophylaxis.
Zyngier I, Torres A, Cassano-Santos U, Cassano-Santos U, et al · · 2025 · cited 1× · PMID 40536497 · DOI 10.1097/hc9.0000000000000732 -
Update on the Evaluation and Management of Portal Hypertension.
Aitcheson G, Cezar C, John I, John BV. · · 2021 · cited 1× · PMID 35465066
Verify or expand the search:
- PubMed search for NCT03720067
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Cirrhosis
Currently open trials in the same condition.
- NCT07322237 — DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis · Phase 4 · recruiting
- NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
- NCT07461545 — Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS · NA · recruiting
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Other Universidade Federal do Rio de Janeiro trials
Trials by the same sponsor.
- NCT07584564 — Application of the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU · NA · 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 NCT03720067 (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 Universidade Federal do Rio de Janeiro
- Last refreshed: 14 May 2019
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/NCT03720067.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing