Observational Prospective Study OPTIMA II - Follow-up

NCT ID: NCT02099565

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 572 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OPTIMA study patients

The study population will consist of OPTIMA study patients who have not been lost for follow-up and have given a written informed consent.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Participation in OPTIMA study;

2. Written informed consent provided prior the start of follow-up in the study

Exclusion Criteria

1. Lost to follow-up patients of OPTIMA study;

2. Subjects who are unwilling or unable to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 150 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Otter, PHD, MD

Role: STUDY_DIRECTOR

AstraZeneca

Yuri Karpov

Role: PRINCIPAL_INVESTIGATOR

Russian Cardiology Research and Production Complex

Locations

Research Site

Moscow, , Russia

Countries

Russia

References

Karpov Y, Logunova N, Tomilova D, Buza V, Khomitskaya Y. Observational Prospective study to esTIMAte the rates of outcomes in patients undergoing PCI with drug-eluting stent implantation who take statins -follow-up (OPTIMA II). Curr Med Res Opin. 2017 Feb;33(2):253-259. doi: 10.1080/03007995.2016.1253552. Epub 2016 Nov 29.

Reference Type: DERIVED

PMID: 27779436 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2910&filename=Synopsis.pdf

CSR synopsis for OPTIMA II NIS study

Other Identifiers

NIS-CRU-CRE-2014/1

Identifier Type: -

Identifier Source: org_study_id