Clinical trial • Phase IV • Cardiology

TEPRENONE (teprenone) for Postoperative atrial fibrillation

Phase IV trial of TEPRENONE (teprenone) for Postoperative atrial fibrillation.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Postoperative atrial fibrillation
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-06-2024
First CTIS Authorization Date
30-09-2024

Trial design

Randomised, comparator arms: test product teprenone (active substance teprenone), granules, oral; reported maximum daily dose 300 mg and max total dose 2400 mg (max treatment period 8); placebo: medium-chain triglycerides (miglyol 812n), cas number: 73398-61-5 (placebo). exact dosing schedule and randomisation/blinding details not specified.-controlled Phase IV trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Comparator arms: Test product TEPRENONE (active substance teprenone), granules, oral; reported maximum daily dose 300 mg and max total dose 2400 mg (max treatment period 8); Placebo: Medium-chain triglycerides (Miglyol 812N), CAS Number: 73398-61-5 (placebo). Exact dosing schedule and randomisation/blinding details not specified.
Target Sample Size
146
Trial Duration For Participant
8

Eligibility

Recruits 146 No vulnerable population selected; no specific consent or assent handling described..

Pregnancy Exclusion
Pre-menopausal women who are nursing, pregnant, or of child-bearing potential
Vulnerable Population
No vulnerable population selected; no specific consent or assent handling described.

Inclusion criteria

  • {"criterion_text":"- Aged between 18 and 80 years old"}
  • {"criterion_text":"- Elected for cardiothoracic surgery for mitral valve stenosis or regurgitation, and/or aortic valve stenosis or regurgitation, and/or coronary artery disease"}

Exclusion criteria

  • {"criterion_text":"- Documented history of AF"}
  • {"criterion_text":"- Not able to undergo the complete study protocol"}
  • {"criterion_text":"- Previous cardiothoracic surgery"}
  • {"criterion_text":"- Doubt about compliance"}
  • {"criterion_text":"- Pre-menopausal women who are nursing, pregnant, or of child-bearing potential"}
  • {"criterion_text":"- Chronic malabsorption"}
  • {"criterion_text":"- Any documented or suspected malignancy or history of malignancy within 1 year prior to screening, except appropriate treated basal cell carcinoma or in situ carcinoma of the cervix"}
  • {"criterion_text":"- Currently enrolled in another drug trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Assessment of Postoperative atrial fibrillation incidence, by Holter monitoring","definition_or_measurement_approach":"Assessment by Holter monitoring to measure incidence of postoperative atrial fibrillation."}

Secondary endpoints

  • {"endpoint_text":"- The secondary trial endpoints are assessments of activation of HSPs by biochemical analysis and microscopic imaging; in blood, atrial tissue and epicardial adipose tissue","definition_or_measurement_approach":"Assessments of activation of heat shock proteins (HSPs) by biochemical analysis and microscopic imaging in blood, atrial tissue and epicardial adipose tissue."}

Recruitment

Planned Sample Size
146
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
146

Netherlands

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
14
Number Of Sites
1
Number Of Participants
146

Sites

Site Name
Stichting Amsterdam UMC
Department Name
Physiology/Cardiothoracic surgery
Principal Investigator Name
Kennedy Silva Ramos
Principal Investigator Email
k.silvaramos@amsterdamumc.nl
Contact Person Name
Kennedy Silva Ramos
Contact Person Email
k.silvaramos@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Stichting Amsterdam UMC
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Third parties

  • {"country":"Netherlands","full_name":"Stichting Amsterdam UMC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
TEPRENONE
Active Substance
TEPRENONE (teprenone)
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus:2
Maximum Dose
300 mg (max daily dose)
Investigational Product Name
Medium-chain triglycerides (Miglyol 812N), CAS Number: 73398-61-5
Modality
Other

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