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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
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).
Inflammatory markers will be assessed at baseline (week 2), week 6, week 18 and
week 26. Inflammatory markers to be analyzed are the following: C-reactive
protein, amyloid A and interleukin 6.
From the exercise tolerance tests the time to onset of 1 mm ST depression, time to
onset of angina and total exercise time will be assessed at baseline (week 2),
week 18 and week 26.
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Rijeka, Croatia
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Zagreb, Croatia
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Ostrava-Kunčice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Příbram, Czechia
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Rokycany, Czechia
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Tallinn, Estonia
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Tartu, Estonia
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Debrecen, Budapest, Hungary
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