NCT04347434RecruitingPhase 4
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
Assessment of the Effects of Long-term Lipid-lowering Therapy on Parameters of Electrical Myocardial Heterogeneity, Myocardial Deformation Characteristics, Vascular Rigidity, and Quality of Life in Patients With Primary STEMI or NSTEMI
Source: ClinicalTrials.gov · Last updated 24 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In a single-center, open-label, prospective, controlled, clinical study, it is planned to include 300 patients hospitalized in the cardiology department of SBHI Penza regional clinical hospital n.a. N.N. Burdenko. Recruitment of patients will be carried out at the Department of Therapy of the Medical Institute of the Penza State University. Patients meeting the inclusion criteria and not meeting the exclusion criteria will be included in the study. Initially, lipid-lowering treatment with atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy. If there is no achievement of the target level of LDL-C, ≤1.5 mmol / L after 5-6 weeks from the AMI onset, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day. Standard AMI treatment includes dual antiplatelet therapy, ACE inhibitors, beta-blockers (if indicated). Prescription of proton pump inhibitors and nitrates is possible (if indicated). The total follow-up is 96 weeks. Prescreening - 600 people; screening and randomization - 300 people. Parameters of electrical myocardial heterogeneity, myocardial deformation characteristics, vascular rigidity, and quality of life will be assessed according to the study plan.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 20 Mar 2020
- Start date
- 12 Feb 2020
- Primary completion date
- 12 Nov 2027
- Lead sponsor
- Penza State University
- Diseases
- Coronary artery disease
- NCT number
- NCT04347434
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From 12 Feb 2020 to the primary completion date, 12 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The development of acute heart failure III-IV prior to randomization
- Severe concomitant diseases in the stage of decompensation.
- Alcohol abuse, drug addiction.
- Other serious concomitant diseases that exclude the possibility of study participation.
Other illness
- Recurrent or repeated myocardial infarction.
- Congenital and acquired heart diseases.
- Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg
- Diabetes mellitus (DM) type 1 and 2.
Lab values
- Current existence of severe anemia (Hb \< 100 g/L)
- Chronic kidney disease (creatinine clearance less than 30 ml / min / 1.73 m2 according to the CKD-EPI).
Other
- Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
- Individual intolerance to statins, ezetimibe.
- Non-sinus rhythm, established artificial pacemaker.
- Sinoatrial and atrioventricular blockade of 2-3 degrees.
- QRS complex exceeding 100 ms.
- The presence of severe LV hypertrophy according to echocardiography.
- Non-corrected thyroid dysfunction with hyper / hypothyroidism.
- Body mass index (BMI) ≥35 kg / m2.
- Pregnancy, lactation.
- Participation in other clinical trials within the last two months.
Who the study is looking for
- 1\. Signed Informed Consent Form 2 Primary STEMI or NSTEMI confirmed by ECG, troponin I and CPK-MB levels, coronary angiography.
- 3\. Presence of an infarct-related artery according to coronary angiography.
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Valentin Oleynikov Coordinator of this site? Confirm its status | Penza | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.