PRIDE. Assessment of the Efficacy, Adherence and Tolerability of the Single Pill Combination Bisoprolol/Perindopril
Condition: Coronary Artery Disease; Myocardial Infarction; Arterial Hypertension
MeSH terms: Hypertension; Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      This non-interventional, ambispective study was aimed at evaluating the effectiveness,
      safety, and tolerability of bisoprolol and perindopril SPC in previous myocardial infarction
      patients with HTN and CAD treated with the drug for 12 weeks in the daily clinical practice.
      SPC will be used according to the approved instruction for medical use of the medicine.

      This is a multi-centre, observational, incomparative, ambispective study, which will
      retrospectively and prospectively collect clinical variables and socio-demographic data from
      medical records of patients with HTN and previous MI initiated with bisoprolol/perindopril
      SPC in real life settings.
    

Detailed description: 
      This is a multi-centre, observational, incomparative, ambispective study, which will
      retrospectively and prospectively collect clinical variables and socio-demographic data from
      medical records of patients with HTN and previous MI initiated with bisoprolol/perindopril
      SPC in real life settings.

      Baseline data will be collected retrospectively from medical records of stable CAD patients
      with HTN and a history of MI, including disease history of the patient. To be included in the
      study for further prospective observation a patient should have been administered bisoprolol/
      perindopril SPC within first three months before the Index Date. (Fig.1). Therefore, criteria
      for non-inclusion or inclusion of the patient in the study are to be retrospectively
      evaluated by the investigator using recorded clinical data available from medical records.
      Once a physician makes decision to include a patient in the study and, in particular, on the
      prospective observation for 3 months, a visit to the clinic for obtaining signed patient's
      consent to participate in the study should be appointed and made within 1 month from the
      Index Date.

      Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion
      criteria for entering the study allows mitigating a potential risk of deliberative medicine
      administration within the observational program. Such studies are carried out in case of
      observational programs when the studied drug is administered in line with indications
      according to the instruction for its medical use.

      Several multicenter, non-interventional, open, incomparable studies have been performed with
      bisoprolol/perindopril SPC in patients with HTN and coronary heart disease. A total of 70
      general practitioners and cardiologists from primary care facilities will participate in the
      program. Each doctor will include about 7-8 patients. In total, it is planned to include at
      least 500 patients.
    

Intervention name(s): in daily everyday routine practice
Intervention type(s): Drug
Intervention description(s): patients with HTN and CAD treated with the the single pill combination bisoprolol/perindopril for 12 weeks in the daily clinical practice Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion criteria for entering the study allows mitigating a potential risk of deliberative medicine administration within the observational program.
Other intervention name(s): Baseline data will be collected retrospectively from medical records of stable CAD patients with HTN and a history of MI, including disease history of the patient.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        CAD patients with previous MI and HTN