Cross-over Study of Coronary Risk Factors With a Polypill
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
Open-label, randomized, cross-over study conducted in a single center, applied to patients receiving a polypill with 100 mg of acetyl salicylic acid and different doses of ramipril and atorvastatin for indication of secondary prevention according to clinical practice, with objective of analyzing the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the polypill and another of 3 months with the components separately.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Polypill of acetylsalicylic acid, ramipril and atorvastatin
DrugAdministration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more
Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin
DrugPatients will be receiving during 3 months more the same components acetylsalicylic acid, ramipril and atorvastatin than with the polypill
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: PolypillExperimental treatment 1 intervention
Group B: Drugs taken separatelyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
LDL-cholesterol
Mean of absolute level of LDL cholesterol
Time frame
Months 2 and 3 vs. Months 5 and 62
Systolic blood pressure
Mean of absolute level of systolic blood pressure
Time frame
Months 2 and 3 vs. Months 5 and 6Sponsors and contacts
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Source ClinicalTrials.gov