Cardiovascular diseases
Conditions
Interventions
Product Name: DG-051
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
deCODE genetics ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 40 and 80. 2. Documented history of MI at least 30 days from the time of randomization and within the past 10 years, secondary to coronary artery disease: Previous MI will be confirmed from source documents (e.g. admission records, discharge summaries, labs etc) by elevated cardiac enzymes (total CK or CK-MB > 2X upper limit of normal or troponin levels > upper limit of normal) and/or changes in ECG (including presence of Q wave = 40 msec in at least two contiguous ECG leads or a new dominant R wave in V1). 3. Signed informed consent form. 4. Females must be surgically sterile or at least 2 years post-menopausal. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test within 24 hours of first administration of study medication regardless of childbearing potential. Eligible male patients must informfemale partners of their participation in the study and use at least 1 barrier method of birth control. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Confirmed diagnosis of congestive heart failure (CHF) and having symptoms greater-than or equal to NYHA class III (appendix 13.2) at any time during 3 months prior to randomization. 2. Any experimental treatment within 30 days from randomization or planned before study completion. 3. Acute CV event (such as ACS / MI or stroke) less than 30 days prior to enrollment. 4. Presence of active hepatic disease or AST and/or ALT > 2 X ULN. 5. Renal insufficiency defined as a creatinine clearance of < 30 mL/minute (calculated using the Cockcroft – Gault formulae). 6. Immunocompromised patients due to treatment with immunosuppressive and/or cytotoxic drugs or systemic corticosteroids within 6 weeks of randomization (inhaled or nasal corticosteroids are allowed). 7. Patients with HIV positive serology. 8. Major surgery performed within 6 weeks prior to scheduled day of randomization. 9. Any other intercurrent illness or other condition, which, in the investigator’s judgment, will interfere with the patient’s participation in this study or interpretation of the data (e.g., cold and/or flu symptoms at randomization). 10. Patients not willing to return for follow-up or with known history of non-compliance. 11. Patients who consume more than 2 alcoholic drinks/day or =10 drinks/week, or have a history of alcohol abuse within the past 2 years in the investigator’s opinion. Patients must agree to comply with the restrictions on alcohol (=2 drinks/day and no alcohol intake within 48 hours of study visits). 12. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study. 13. History of seizure disorder. 14. Patients initiating or changing lipid lowering medication or hormone replacement therapy within 30 days prior to randomization or planning to modify dosing during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the safety and tolerability of DG-051 when administered for 12 weeks in patients with a history of MI. 2. To characterize DG-051 pharmacokinetics and whole blood stimulated LTB4 production in a subset of patients, during 12 weeks of dosing to patients with a history of MI.;Secondary Objective: Exploratory Objective(s): 1. To explore the effects of DG-051 therapy on levels of other biomarkers of interest (sICAM, sVCAM, MCP-1, CRP, plasma MPO). 2. To explore the influence of genetic variants related to risk of cardiovascular disease (e.g., 5-lipoxygenase activating protein (FLAP), Leukotriene A4 Hydrolase (LTA4H), chromosome 9 markers near the CDK2NA gene) on biomarkers.;Primary end point(s): 1. There is not a formal statistical endpoint that corresponds to the primary safety objective of the study because there is not a particular safety variable (e.g., a single adverse event or a single laboratory analyte) that is of special interest. However, the incidence of reported adverse events and mean changes from baseline in laboratory test results in each DG-051 treatment group and placebo will be summarized. Given the population under study a certain number (10-20) of cardiovascular events are also expected. These CV events will also be summarized in tabular form. 2. Percent change from baseline to Final Visit on treatment (Week 12 LOCF) in whole blood stimulated LTB4 production, comparing each DG-051 group to placebo, are the primary pharmacodynamic endpoints | — |
Countries
Iceland
Outcome results
None listed