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Myocardial InfarctionPhase 2CHIARA MIA 2NCT02976467

A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction

A Phase 2 study testing Fulacimstat (BAY1142524) in people with Myocardial Infarction, run by Bayer at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 to 79 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Fulacimstat (BAY1142524)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
107 participants
Where
25 sitesin 5 countries
Study dates
30 Dec 2016to 4 Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
  • Diagnosis of STEMI requires the presence of the following three criteria:
  • Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes related to the myocardial infarction
  • New ST elevation indicating myocardial infarction
  • Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and/or elevation creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
  • At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size >10% LV mass (as measured by LGE-MRI, central-blinded evaluation)

Who cannot join

  • Contraindication to perform contrast-enhanced cardiac MRI
  • LVEF < 20%
  • History of heart failure or LVEF < 50% before occurrence of the first STEMI
  • Infarct size > 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
  • NYHA (New York Heart Association) class IV at randomization
  • Any planned cardiac intervention after baseline MRI or any other planned operations
Show all 10Show fewer
  • Non-ischemic causes for cardiomyopathy
  • Diagnosis of atrial fibrillation
  • Systolic blood pressure < 100 mm Hg or > 180 mm Hg; diastolic blood pressure < 50 mm Hg or >110 mm Hg, heart rate < 50 or >100 beat/minute; mean of triplicate values at randomization
  • Clinically relevant hepatic dysfunction

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

Israel6 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 9103102

  • Study site

    Jerusalem, 9112001

  • Study site

    Petah Tikva, 4941492

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Czechia5 sites

  • Study site

    Kladno, 27259

  • Study site

    Prague, 100 34

  • Study site

    Prague, 140 21

  • Study site

    Prague, 150 06

  • Study site

    Prague, 150 30

Other trials in Czechia

Italy5 sites

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Brescia, Lombardy, 25123

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Milan, Lombardy, 20138

  • Study site

    Monza-Brianza, Lombardy, 20090

Other trials in Italy

Spain5 sites

  • Study site

    Babio - Beade, Pontevedra, 36312

  • Study site

    Barcelona, 08036

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28040

  • Study site

    Valencia, 46026

Other trials in Spain

Germany4 sites

  • Study site

    Berlin, 13353

  • Study site

    Dortmund, North Rhine-Westphalia, 44137

  • Study site

    Erfurt, Thuringia, 99089

  • Study site

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Multicenter Study to Assess the Safety and Efficacy of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Reduced Left-ventricular Ejection Fraction (LVEF≤ 45%) After Acute Myocardial Infarction

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.

Being tested
Fulacimstat (BAY1142524), Placebo
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fulacimstat (BAY1142524)Drug

    25 mg BAY 1142524 are given twice daily over a treatment period of 6 months

  • PlaceboDrug

    Matching placebo tablets are given twice daily over a treatment period of 6 months

Study groups in NCT02976467
Study groupRoleWhat they receive
Fulacimstat (BAY1142524)Experimental30 patients with left-ventricular dysfunction after acute myocardial infarction
Receives: Drug: Fulacimstat (BAY1142524)
PlaceboPlacebo comparator30 patients with left-ventricular dysfunction after acute myocardial infarction
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in left-ventricular ejection fraction (LVEF)

    Measured: At 6 months

  2. Change in end diastolic volume index (EDVI)

    Measured: At 6 months

  3. Change in end systolic volume index (ESVI)

    Measured: At 6 months

Secondary outcomes (2)

  1. Number of patients with adverse events

    Measured: Up to 7 months

  2. Number of patients with serious adverse events

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study start30 Dec 2016
  3. Primary completion31 Jul 2018
  4. Study completion4 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02976467
Sponsor's protocol ID
16673
Other IDs
2016-002167-33, 2016
Acronym
CHIARA MIA 2
Status last verified
Aug 2019
First submitted
24 Nov 2016
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Duengen HD, Kim RJ, Zahger D, Orvin K, Kornowski R, Admon D, Kettner J, Shimony A, Otto C, Becka M, Kanefendt F, Romo AI, Hasin T, Ostadal P, Rojas GC, Senni M; GROUP investigators of the CHIARA MIA 2 trial. Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial. Am Heart J. 2020 Jun;224:129-137. doi: 10.1016/j.ahj.2020.01.012. Epub 2020 Jan 25.

    PubMed 32375104

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulacimstat (BAY1142524) in people with Myocardial Infarction, run by Bayer at 25 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Israel, Czechia, Italy, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in left-ventricular ejection fraction (LVEF) (time frame: At 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02976467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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