Clinical study to evaluate the effectiveness of the active ingredient Bempedoic acid in patients following myocardial infarctions insufficiently treated with the drugs atorvastatin plus ezetimibe.

Phase 1

• Conditions: Patients following acute percutaneous coronary intervention for STEMI or NSTEMI insufficiently treated with high-intensity oral lipid lowering therapy; MedDRA version: 20.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10064347Term: Non ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-003526-50-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-27
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1.Men, women, inter/diverse* aged = 18 and = 85 years
2.Signed written informed consent
3.NSTEMI or STEMI with successful PCI within 7 days prior to screening
4.Therapy naïve LDL-C > 100 mg/dl
5.Ensured compliance: patient should be able to cooperate with protocol regimen and follow-up
6.*Patients without childbearing potential defined as follows:
•at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
•hysterectomy or uterine agenesis or
•= 50 years and in postmenopausal state for > 1 year or
•< 50 years and in postmenopausal state for > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
or
*Patients of childbearing potential:
•who are practising sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
•who have same sexual relationships only and/or have sexual relationships with sterile partners or
•who are sexually active with fertile partner, have a negative pregnancy test dur-ing screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial and for a period of 4 days following the last administration of study medication.
**The following methods of contraception are acceptable (failure rate of < 1% per year/highly effective):
-combined (estrogen and progesterone containing) hormonal contraception (oral/intravaginal/transdermal) associated with inhibition of ovulation,
-progestogen-only hormonal contraception (oral, injectable, implantable) as-sociated with inhibition of ovulation,
-intrauterine device (IUD),
-intrauterine hormone-releasing system (IUS)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

1. History of gout
2. Scheduled surgery within the next 4 months
3. Patients who cannot come to revisits
4. Participation in another clinical trial within 30 days before study start or during the trial
5. Hypersensitivity to any of the components of the medications used
6. Pregnancy / Breast-feeding
7. Patients with severe renal disorders (defined as eGFR <30 ml/min/1,73 m2) or patients requiring dialysis with endstage renal disease
8. Patients with history of tendon disorders or tendon rupture
9. Person who is placed in an mental institution by court or official order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified