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Atrial FibrillationPhase 2PROMISE-AFNCT03906799

Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)

A Phase 2 study testing OMT-28 in people with Atrial Fibrillation, run by Omeicos Therapeutics GmbH at 25 sites in 4 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

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
OMT-28
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
25 sitesin 4 countries
Study dates
19 Mar 2019to 20 Mar 2020
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females between 18 and 85 years of age.
  • Patients with persistent AF for > 7 days but ≤ 3 months suitable for electrical DCC.
  • Male patients must be surgically sterile for at least 90 days or will be required to use a male condom with spermicide, and will refrain from donating sperm from the time of the first dose until 90 days after the last dose of study medication.
  • Females of childbearing potential (postmenarchal, not surgically sterile, premenopausal) will agree to follow contraception requirements from the time of signing the Informed Consent Form (ICF) until 90 days after the last administration of study drug.
  • Willing and able to give written informed consent before any study-related procedure.
  • Willing and able to attend all the visits scheduled in the study.
Show all 25Show fewer
  • Main Exclusion Criteria:
  • Patients with known concurrent temporary secondary causes of AF
  • Patients that have undergone surgical or catheter ablation for AF or atrial flutter.
  • Patients with an existing cardiac treatment device, pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
  • Patients with a history of ECG abnormalities that, in the opinion of the investigator (or designee), render the patient unsuitable for the study.
  • Patients with congestive heart failure (NYHA class III and IV).
  • Patients with left atrium size ≥ 55 mm.
  • Patients with left ventricular ejection fraction ≤ 40 %.
  • Known presence of a thrombus in the left atrial appendage, left atrium, left ventricle, aorta, or intracardial mass.
  • Patients with moderate or severe mitral stenosis, mitral valve rheumatic disease, unresected atrial myxoma, or a mechanical heart valve and/or other conditions, such as pulmonary embolism, considered to be formal indication for conventional anticoagulation.
  • Patients with any acute coronary event, stroke, or percutaneous coronary intervention within 6 months prior to randomization or who are receiving dual antiplatelet therapy.
  • Uncontrolled/therapy-resistant bradycardia and/or uncontrolled/therapy-resistant hypertension within a 3-month period prior to randomization.
  • Patients having more than two DCCs in the last 6 months. Any unsuccessful pharmacological and/or electrical cardioversion (within prior 3 months).
  • Patients with signs of bleeding or conditions associated with a high risk of bleeding.
  • Patients taking antiarrhythmic agents within 3 days of planned randomization will be excluded.
  • Patients concurrently participating in another study or unable to communicate.
  • Patients with active cancer, chronic kidney disease or intercurrent illness.
  • Pregnant or breastfeeding women.
  • Patients taking concomitant medication.

Who cannot join

None listed.

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

Ukraine13 sites

  • Site 102

    Cherkasy, 18009

  • Site 110

    Ivano-Frankivsk, 76018

  • Site 104

    Kharkiv, 61018

  • Site 107

    Kharkiv, 61176

  • Site 108

    Khmelnytskyi, 29000

  • Site 113

    Kiev, 02660

  • Site 106

    Kiev, 03038

  • Site 101

    Kiev, 03115

  • Site 109

    Kiev, 03680

  • Site 112

    Kiev, 04050

  • Site 105

    Odesa, 65025

  • Site 103

    Uzhhorod, 88000

  • Site 111

    Zhytomyr, 10002

Other trials in Ukraine

Hungary6 sites

  • Site 205

    Budapest, 1023

  • Site 201

    Budapest, 1122

  • Site 203

    Debrecen, 4032

  • Site 206

    Hódmezővásárhely, 6800

  • Site 202

    Pécs, 7624

  • Site 204

    Zalaegerszeg, 8900

Other trials in Hungary

Bulgaria3 sites

  • Site 401

    Sofia, 1527

  • Site 404

    Stara Zagora, 6004

  • Site 402

    Varna, 9000

Other trials in Bulgaria

Czechia3 sites

  • Site 301

    Kolín, 28002

  • Site 303

    Pilsen, 30460

  • Site 302

    Slaný, 27401

Other trials in Czechia

About this study

Official title: A Placebo-controlled, Double-blind, Randomized, Dose-finding Phase II Study on OMT-28 in MaIntenance of Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation (PROMISE-AF)

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF.

Read the detailed description

This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in patients with persistent AF. At randomization, the duration of the current episode of persistent AF must be shown to be greater than 7 days and not greater than 3 months, as confirmed by two ECGs (one ECG must be a 12-lead ECG) and further patient enquiry (including doctor visits, hospital admissions, symptom onset, etc.).

A sample size re-evaluation will be performed to avoid an underpowered study because of imprecise estimates for the study population or overoptimistic parameter estimates. Therefore, an interim analysis will re-evaluate sample size assumptions after approximately 15 patients per study arm (~50 % of planned sample) have completed the treatment phase (Visit 8) of the study. Predefined rules will govern the decision for adjustment of sample size.

Patients will be monitored for cardiac events throughout the study using an Implantable Cardiac Monitor (ICM). Safety will be monitored throughout the study. Blood samples will be collected in pre-specified windows for popPK analysis and at pre-specified timepoints for PK/PD analysis. Patients will be provided with a diary to record timing of drug administration and clinical symptoms while not on site. Diaries will be reviewed and checked for compliance at each non-resident visit to the clinical site.

Being tested
OMT-28, Placebo
Keywords
Atrial Fibrillation, Electrical Cardioversion, Dose-finding
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • OMT-28Drug

    1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

  • PlaceboDrug

    1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).

Study groups in NCT03906799
Study groupRoleWhat they receive
Low OMT-28ExperimentalVerum, low OMT-28
Receives: Drug: OMT-28
Middle OMT-28ExperimentalVerum, middle OMT-28
Receives: Drug: OMT-28
High OMT-28ExperimentalVerum, high OMT-28
Receives: Drug: OMT-28
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Assessment of AF Burden After OMT-28 Administration

    To assess the AF burden, based on data collected via the implantable cardiac monitor BioMonitor 2-AF, of three different doses of OMT-28 administered once daily versus placebo in the maintenance of normal sinus rhythm after electrical direct current cardioversion (DCC) in patients with persistent AF

    Measured: Up to 4.5 months

Secondary outcomes (3)

  1. Incidence of Treatment-Emergent Adverse Events

    To assess the incidence of treatment-emergent Adverse Events of three different doses of OMT-28 administered once daily versus placebo after electrical DCC in patients with persistent AF.

    Measured: Up to 4.5 months

  2. Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - AUC

    To assess the pharmacokinetic (PK) parameter AUC of OMT-28 administered once daily in patients with persistent AF, by means of population PK (popPK) analysis.

    Measured: Up to 3.5 months

  3. Assessment of Pharmacokinetic (PK) Parameters of OMT-28 - Cmax

    To assess the pharmacokinetic (PK) parameter Cmax of OMT-28 administered once daily in patients with persistent AF, by means of population PK (popPK) analysis.

    Measured: Up to 3.5 months

Timeline

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

  1. First posted8 Apr 2019
  2. Study start19 Mar 2019
  3. Primary completion20 Nov 2019
  4. Study completion20 Mar 2020

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03906799
Sponsor's protocol ID
OMT28-C0201
Acronym
PROMISE-AF
Status last verified
Mar 2019
First submitted
20 Mar 2019
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schunck WH, Konkel A, Fischer R, Weylandt KH. Therapeutic potential of omega-3 fatty acid-derived epoxyeicosanoids in cardiovascular and inflammatory diseases. Pharmacol Ther. 2018 Mar;183:177-204. doi: 10.1016/j.pharmthera.2017.10.016. Epub 2017 Nov 7.

    PubMed 29080699

  • Fischer R, Konkel A, Mehling H, Blossey K, Gapelyuk A, Wessel N, von Schacky C, Dechend R, Muller DN, Rothe M, Luft FC, Weylandt K, Schunck WH. Dietary omega-3 fatty acids modulate the eicosanoid profile in man primarily via the CYP-epoxygenase pathway. J Lipid Res. 2014 Jun;55(6):1150-64. doi: 10.1194/jlr.M047357. Epub 2014 Mar 16.

    PubMed 24634501

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMT-28 in people with Atrial Fibrillation, run by Omeicos Therapeutics GmbH at 25 sites in 4 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 25 inclusion and 0 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 9 Sep 2021. 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 Ukraine, Hungary, Bulgaria, Czechia. 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?

Assessment of AF Burden After OMT-28 Administration (time frame: Up to 4.5 months). 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 NCT03906799, which also lists 2 linked publications.

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 9 Sep 2021.

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