Observational Prospective Study OPTIMA II - Follow-up

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Clinical Trial

— OPTIMAII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099565
• Other study ID #: NIS-CRU-CRE-2014/1
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: February 24, 2016
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 150 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	No
Secondary	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)	No
Secondary	LDL-C level.	LDL-C level.	from 31 March 2014 to 31 March 2015	No
Secondary	Lipoprotein A level.	Lipoprotein A level.	from 31 March 2014 to 31 March 2015	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   CSR synopsis for OPTIMA II NIS study