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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02099565
First received: March 25, 2014
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). [ Time Frame: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy. [ Time Frame: Up to 4 years after PCI ] [ Designated as safety issue: No ]
    The proportion of patients who take statins during 4 years after PCI and who discontinue statin therapy.

  • The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l. [ Time Frame: from 1 Jul 2015 to 30 Sep 2015 (after study report preparation) ] [ Designated as safety issue: No ]
    The proportion of patients who achieve target level of Low Density Lipoprotein Cholesterol (LDL-C) less than 1,8 mmol/l.

  • LDL-C level. [ Time Frame: from 31 March 2014 to 31 March 2015 ] [ Designated as safety issue: No ]
    LDL-C level.

  • Lipoprotein A level. [ Time Frame: from 31 March 2014 to 31 March 2015 ] [ Designated as safety issue: No ]
    Lipoprotein A level.

  • To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire [ Time Frame: Up to 4 years after PCI ] [ Designated as safety issue: No ]
    To estimate adherence to the therapy with statins according to questionnaire based on results of questionnaire

  • 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) [ Time Frame: Up to 4 years after PCI ] [ Designated as safety issue: No ]
    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

  • To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI [ Time Frame: from 1 Jul 2015 to 30 Sep 2015 ] [ Designated as safety issue: No ]
    To estimate Seattle angina questionnaire (SAQ) score 4 years after PCI


Estimated Enrollment: 600
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099565

Contacts
Contact: Natalia Logunova +7 495 799 56 99 ext 1125 ClinicalTrialTransparency@astrazeneca.com
Contact: Nikolay Suvorov +7 495 799 56 99 ext 1214 Nikolay.Suvorov@AstraZeneca.com

Locations
Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karin Otter, PHD, MD AstraZeneca
Principal Investigator: Yuri Karpov Russian Cardiology Research and Production Complex
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02099565     History of Changes
Other Study ID Numbers: NIS-CRU-CRE-2014/1
Study First Received: March 25, 2014
Last Updated: September 3, 2014
Health Authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials

Keywords provided by AstraZeneca:
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Statins
LDL-cholesterol
Inflammatory markers
Percutaneous Coronary Intervention (PCI)

ClinicalTrials.gov processed this record on September 18, 2014