Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04656847
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2020-11-30
Brief Title:
PRIDE Assessment of the Efficacy Adherence and Tolerability of the Single Pill Combination BisoprololPerindopril
Sponsor:
Servier Russia
Organization:
Servier Russia
Study Overview
Official Title:
Assessment of the Efficacy Adherence and Tolerability of the Single Pill Combination BisoprololPerindopRil In Patients With Previous Myocardial Infraction With Arterial Hypertension in the Daily Clinical practicE
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIDE
Brief 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 bisoprololperindopril SPC in real life settings
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 bisoprololperindopril 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 bisoprololperindopril 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 Fig1 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 patients consent to participate in the study should be appointed and made within 1 month from the Index Date
Retrospective screening and evaluation of patients 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 bisoprololperindopril 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
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 Fig1 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 patients consent to participate in the study should be appointed and made within 1 month from the Index Date
Retrospective screening and evaluation of patients 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 bisoprololperindopril 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None