TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)
NCT ID: NCT04162561
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
70 participants
OBSERVATIONAL
2017-12-31
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Allicor on Patients After Coronary Arteria Revascularization Treatment
NCT05803759
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
NCT05624658
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
NCT04347434
Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)
NCT00730132
The Effects of Allicor on Patients After Revascularization Treatment During a Year
NCT05813171
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The first visit (V0) is an inclusion in the study. During this visit, an attempt to correct or start (if it had not been started before) antiplatelet, hypolipidemic, antihypertensive and antianginal therapy will be made.
The second visit (V1) is planned for each patient three months after the first visit (V0). During the second visit number of patients who reached target levels of BP, LDL-C, frequency of angina attacks will be assessed. If necessary, correction of therapy will also be made.
The third visit (V2) is planned for each patient one year after the first visit (V0). During the third visit reaching target BP, LDL-C levels, frequency of angina attacks will be assessed. If necessary, therapy correction will be recommended.
The last visit - telephone contact with patients - is expected in 2 years after the first visit. During that visit it is planned to assess life status, complications and current medical treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Patients with documented IHD
Assessment of patients' quality of life with the use of the Seattle Angina Questionnaire (SAQ), blood pressure levels (using the Korotkoff method, blood pressure is measured 3 times with 1-minute intervals on the hand with the higher blood pressure levels while sitting calm after a 5-minutes rest), laboratory methods (lipids, glycosylated hemoglobin levels), patients' adherence to treatment (original questionnaire), quality of patients' therapy taken at the time of visit, necessity of invasive coronary revascularization procedures (during all visits).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Documented IHD:
1. Positive results of the angina questionnaire (typical angina)
2. Positive exercise electrocardiography or stress echocardiography, plus one of the following criteria:
* ischemia documented by scintigraphy study
* invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery)
* previous coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG))
* previous myocardial infarction
* patients who had elective PCI or CABG
Exclusion Criteria
* Patients' refuse to follow the study's graphic of doctors' visits
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Research Center for Preventive Medicine
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergey Martsevich, PhD
Role: STUDY_CHAIR
National Research Center for Preventive Medicine
Ekaterina Zharkova, MD
Role: PRINCIPAL_INVESTIGATOR
National Research Center for Preventive Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Research Center for Preventive Medicine
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Martsevich S.Yu., Zharkova E.D., Kutishenko N.P., Lukina Yu.V., Tolpygina S.N., Voronina V.P., Zagrebelnyy A.V. An Attempt to Accord the Quality of Therapy of Stable Coronary Heart Disease Patients with Current Clinical Guidelines (ALIGN study): Design and the First Results. Rational Pharmacotherapy in Cardiology. 2020;16(1):75-81. (In Russ.) https://doi.org/10.20996/1819-6446-2020-02-08
Martsevich S.Y., Lukina Y.V., Zharkova E.D., Kutishenko N.P. Treatment Adherence to Drug Therapyin Patients with Stable Coronary Artery Disease During the COVID-19 Pandemic. Rational Pharmacotherapy in Cardiology. 2021;17(1):99-104. https://doi.org/10.20996/1819-6446-2021-01-06
Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. Assessment of the Quality of Drug Therapy in Patients with Stable Coronary Artery Disease in the Second Stage of the ALIGN Study. Rational Pharmacotherapy in Cardiology. 2022;18(3):306-310. (In Russ.) https://doi.org/10.20996/1819-6446-2022-06-12
Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. The quality of received drug therapy in patients with stable coronary heart disease according to the ALIGN (TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes) study. Cardiovascular Therapy and Prevention. 2022;21(9):3371. (In Russ.) https://doi.org/10.15829/1728-8800-2022-3371
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROFILE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.