Angina
Conditions
Brief summary
To evaluate and compare the safety and efficacy of amlodipine, atorvastatin and the combination in patients with symptomatic myocardial ischemia. Amlodipine's use in angina has been well documented in clinical trials such as the Circadian Anti-Ischemia Program in Europe (CAPE), but the impact on vascular inflammation in clinical practice has not been tested. Furthermore, the potentially synergistic benefit of atorvastatin and amlodipine on inflammation ischemic activity has not been studied.
Interventions
DRUGamlodipine
DRUGatorvastatin
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Holter monitoring at baseline which demonstrates a total of 15 minutes of ischemia and/or 3 ischemic events per 48 hours. * Total cholesterol \> 5.2 mmol/L (200 mg/dL) on diet alone.
Exclusion criteria
* Myocardial infarction within 2 months prior to the study. * Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26). | — |
Secondary
| Measure | Time frame |
|---|---|
| week 26. Inflammatory markers to be analyzed are the following: C-reactive | — |
| protein, amyloid A and interleukin 6. | — |
| Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and | — |
| onset of angina and total exercise time will be assessed at baseline (week 2), | — |
| week 18 and week 26. | — |
| From the exercise tolerance tests the time to onset of 1 mm ST depression, time to | — |
Countries
Croatia, Czechia, Estonia, Hungary, Latvia, Norway, Poland, Romania, Slovakia, South Africa, Turkey (Türkiye)
Outcome results
None listed