A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Heart Attack
- Conditions
- Myocardial InfarctionMedDRA version: 20.0Level: LLTClassification code 10030272Term: Old myocardial infarctionSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000840-75-IT
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 792
1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after providing signed
informed consent, and must adhere to the schedules of activities.
2 Participant must be = 40 years of age at the time of signing the informed consent form (ICF).
3 Participant must:
(a) be 30 to 180 days post-MI (ie, STEMI and NSTEMI) at screening Visit 1.
(b) have persistent inflammation, defined as hs CRP = 2 mg/L, as measured centrally at screening Visit 1.
(c) have elevated NT proBNP = 125 pg/mL, as measured centrally at screening Visit 1.
4 Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
5 For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:
(a) Postmenopausal, defined as amenorrhea for = 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
6 Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque, as confirmed by the core laboratory.
Participants will be reassessed for study eligibility before study intervention is administered on Day 1 (Visit 3). Participants should be considered for a high-intensity statin based on existing guidelines for
long-term management of patients after an MI. Participants should ideally be on a stable dose of lipid-lowering therapy throughout the treatment period of the study; therefore, efforts should be made to
maximize statin intensity before randomization. During the study, enrollment may be capped within specific participant subgroups.
In addition to the inclusion criteria specified above, study participants may elect to take part in the Genomics Initiative; participants who chose to do this must provide written informed consent before samples are collected for the optional genetic research that supports the Genomics Initiative.
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 634
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158
1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after providing signed
informed consent, and must adhere to the schedules of activities.
2 Participant must be = 40 years of age at the time of signing the informed consent form (ICF).
3 Participant must:
(a) be 30 to 180 days post-MI (ie, STEMI and NSTEMI) at screening Visit 1.
(b) have persistent inflammation, defined as hs CRP = 2 mg/L, as measured centrally at screening Visit 1.
(c) have elevated NT proBNP = 125 pg/mL, as measured centrally at screening Visit 1.
4 Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
5 For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:
(a) Postmenopausal, defined as amenorrhea for = 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
6 Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque, as confirmed by the core laboratory.
Participants will be reassessed for study eligibility before study intervention is administered on Day 1 (Visit 3). Participants should be considered for a high-intensity statin based on existing guidelines for
long-term management of patients after an MI. Participants should ideally be on a stable dose of lipid-lowering therapy throughout the treatment period of the study; therefore, efforts should be made to
maximize statin intensity before randomization. During the study, enrollment may be capped within specific participant subgroups.
In addition to the inclusion criteria specified above, study participants may elect to take part in the Genomics Initiative; participants who chose to do this must provide written informed consent before samples are collected for the optional genetic research that supports the Genomics Initiative.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method