Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02099565
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2014-03-25
Brief Title:
Observational Prospective Study OPTIMA II - Follow-up
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Observational Prospective Study to esTIMAte the Rates of Outcomes in Patients Undergoing PCI Percutaneuos Coronary Intervention With Drug Eluting Stent DES Implantation Who Take Statins OPTIMA II - Follow-up
Status:
COMPLETED
Status Verified Date:
2016-02
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:
OPTIMAII
Brief Summary:
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events MACCE during 4-year follow-up in patients participated in OPTIMA study In addition the long-term effects of statins on LDL-cholesterol and different biomarkers in patients after drug-eluting stents implantation will be assessed In addition such project implementation will allow to clarify the treatment options used by Russian patients with CAD Coronary Artery Disease after drug-eluting stent implantation The information received in this study will help to optimize management of Russian patients with CAD after PCI in order to improve prognosis and quality of life of these patients
Detailed Description:
This project is 3-years follow-up of OPTIMA study This is an observational retro-prospective study based on the data collected during one visit 4-year after PCI performed at the Russian Cardiological Research Center РКНПК From the date of the study start and until the end of the study investigators will enroll those patients participated in OPTIMA study Only patients who consent to participate in the study and sign the informed consent form after being informed by a physician on the objectives and methods of the study will be enrolled into this project
This study is an observational one and there is no intervention into routine clinical practice either in terms of therapy or special examinations The main point of this project is the data collection using the out-patient medical records or disease history of a patient as well as collection of data received during patient routine examination Data collection will be performed only once during single routine patient visit to treating physician or hospitalized patient examination Study participation will be finished after this visit Data collection will be performed at the visit 4 years after PCI and will include medical history current medications physical examination ECG electrocardiogram and laboratory assessments
The study will be conducted in Russian Federation It is planned that 80-90 of patients participated in OPTIMA study will be enrolled into current project One clinical site - Russian Cardiological Research Center РКНПК - is supposed to participate in this study
The total period of the study is anticipated to be about 18 months
This study is an observational one and there is no intervention into routine clinical practice either in terms of therapy or special examinations The main point of this project is the data collection using the out-patient medical records or disease history of a patient as well as collection of data received during patient routine examination Data collection will be performed only once during single routine patient visit to treating physician or hospitalized patient examination Study participation will be finished after this visit Data collection will be performed at the visit 4 years after PCI and will include medical history current medications physical examination ECG electrocardiogram and laboratory assessments
The study will be conducted in Russian Federation It is planned that 80-90 of patients participated in OPTIMA study will be enrolled into current project One clinical site - Russian Cardiological Research Center РКНПК - is supposed to participate in this study
The total period of the study is anticipated to be about 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None