NCT02099565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
572

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

March 25, 2014

Last Update Submit

February 24, 2016

Conditions

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Keywords

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)StatinsLDL-cholesterolInflammatory markersPercutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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.

    from 1 Jul 2015 to 30 Sep 2015 (after study report preparation)

  • LDL-C level.

    from 31 March 2014 to 31 March 2015

  • 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

    Up to 4 years after PCI

  • +2 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 150 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participation in OPTIMA study;
  • Written informed consent provided prior the start of follow-up in the study

You may not qualify if:

  • Lost to follow-up patients of OPTIMA study;
  • Subjects who are unwilling or unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Moscow, Russia

Location

Related Publications (1)

  • 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.

    PMID: 27779436DERIVED

Related Links

Study Officials

  • Karin Otter, PHD, MD

    AstraZeneca

    STUDY DIRECTOR

  • Yuri Karpov

    Russian Cardiology Research and Production Complex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 31, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

RU(1)