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NCT05775380: PREVALENT
The Role of Pioglitazone in Vascular Transcriptional Remodeling
Phase 4 trial testing Pioglitazone 45 mg in Myocardial Reperfusion Injury in 20 participants. Status unknown.
28 June 2024
Quick facts
| Lead sponsor | University of Campinas, Brazil |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 15 June 2023 |
| Primary completion | 28 June 2024 |
| Estimated completion | 22 December 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Pioglitazone 45 mg — full drug profile →
Conditions studied
- Myocardial Reperfusion Injury — all drugs for Myocardial Reperfusion Injury →
Sponsor
University of Campinas, Brazil
Who can join
Adults 40 to 70, male only, with Myocardial Reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Acute myocardial infarction (AMI) remains the leading cause of death worldwide. In this scenario, early coronary reperfusion is the main therapeutic strategy as it substantially reduces mortality. Paradoxically, however, reperfusion triggers additional tissue damage that accounts for about 50% of the infarcted heart mass, i.e., ischemia and reperfusion injury (IRL). In this context, sphingosine-1-phosphate (S1P) is a sphingolipid synthesized by sphingosine kinases (Sphk), carried in plasma bound to high-density lipoprotein (HDL) and released after cellular damage such as LIR. Particularly, in animal models of AMI, therapies targeting downstream S1P receptor signaling triggered by HDL/S1P are able to promote endothelial barrier functions and attenuate secondary damage to LIR. Thus, the molecular control of sphingosine kinase 1 (Sphk1) transcription during LIR in vivo or during hypoxia/reoxygenation (H/R) in vitro may represent an important mechanism for maintaining endothelial homeostasis since it promotes the generation of S1P and this may promote subsequent HDL enrichment. Thus, the role of pioglitazone hydrochloride 45mg/day for five days in volunteers undergoing coronary artery bypass grafting (BVR) will be investigated in order to verify the vascular expression of SPhk1, transcriptome and vascular proteome remodeling, as well as S1P content in HDL.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05775380
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Other recruiting trials for Myocardial Reperfusion Injury
Currently open trials in the same condition.
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Other University of Campinas, Brazil trials
Trials by the same sponsor.
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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 NCT05775380 (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 Campinas, Brazil
- Last refreshed: 12 January 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/NCT05775380.
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