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NCT02976467: CHIARA MIA 2
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction
Phase 2 trial testing Fulacimstat (BAY1142524) in Myocardial Infarction in 107 participants. Completed in 4 September 2018.
31 July 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 107 |
| Start date | 30 December 2016 |
| Primary completion | 31 July 2018 |
| Estimated completion | 4 September 2018 |
| Sites | 25 locations across Italy, Israel, Germany, Spain, Czechia |
Drugs / interventions tested
- Fulacimstat (BAY1142524) — full drug profile →
- Placebo
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
Bayer — full company profile →
Who can join
Adults 40 to 79, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI). BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in functional parameters of adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 30 patients have to complete treatment with verum and 30 patients have to complete treatment with placebo.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A novel hamster nonalcoholic steatohepatitis model induced by a high-fat and high-cholesterol diet.
Miyaoka Y, Jin D, Tashiro K, Masubuchi S, et al · · 2018 · cited 10× · PMID 29311502 · DOI 10.1538/expanim.17-0126 -
A Chymase Inhibitory RNA Aptamer Improves Cardiac Function and Survival after Myocardial Infarction.
Jin D, Takai S, Nonaka Y, Yamazaki S, et al · · 2019 · cited 9× · PMID 30572223 · DOI 10.1016/j.omtn.2018.11.001
Verify or expand the search:
- PubMed search for NCT02976467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
- NCT03402438 — Renal Impairment Study · Phase 1 · completed
- NCT03412006 — A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes an · Phase 2 · completed
Other recruiting trials for Myocardial Infarction
Currently open trials in the same condition.
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- NCT07301034 — A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, · Phase 3 · recruiting
- NCT07142265 — Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients · recruiting
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Other Bayer trials
Trials by the same sponsor.
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- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet 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 NCT02976467 (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 Bayer
- Last refreshed: 3 September 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/NCT02976467.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing