Observational Prospective Study OPTIMA II - Follow-up (OPTIMAII)

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

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.

Study Overview

• Status: Completed
• Conditions: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

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.

• Study Type: Observational
• Enrollment (Actual): 572

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 150 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Follow-up OPTIMA (NIS-GRU-NEX-2009/) study patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who takes statins at baseline after 4 years after PCI (Percutaneuos Coronary Intervention).	The rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) in patients after drug-eluting stents (DES) implantation who take statins at baseline after 4 years after PCI.	from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.	The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.	Up to 4 years after PCI
The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.	The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.	from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)
LDL-C level.	LDL-C level.	from 31 March 2014 to 31 March 2015
Lipoprotein A level.	Lipoprotein A level.	from 31 March 2014 to 31 March 2015
To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire	To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire	Up to 4 years after PCI
To evaluate proportion of patients who discontinue statin therapy, beta-blockers and ACE (Angiotensin Converting Enzyme) inhibitors therapy and identify their characteristics based on results of questionnaires and CRFs (Case Report Forms)	To evaluate proportion of patients who discontinue statin therapy, beta-blockers and ACE inhibitors therapy and identify their characteristics based on results of questionnaires and CRFs	Up to 4 years after PCI
To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI	To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI	from 1 Jul 2015 to 30 Sep 2015

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Karin Otter, PHD, MD, AstraZeneca; Principal Investigator: Yuri Karpov, Russian Cardiology Research and Production Complex

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR synopsis for OPTIMA II NIS study

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: March 28, 2014
• First Posted (ESTIMATE): March 31, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Inflammatory markers; Statins; LDL-cholesterol; Percutaneous Coronary Intervention (PCI); Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
• Other Study ID Numbers: NIS-CRU-CRE-2014/1