Phase 4 Heart Disease Trial, Recruiting NCT04347434 Sponsor: Penza State University Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT04347434
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have signed a consent form agreeing to take part in the study.
  • People who have been diagnosed with a heart attack (either a STEMI or NSTEMI type), confirmed through heart tracing tests (ECG), blood tests (troponin I and CPK-MB), and a procedure that takes images of the heart's arteries (coronary angiography).
  • People whose heart imaging shows a specific blocked or narrowed artery linked to the heart attack.

Who may not be able to join:

  • People whose heart artery imaging shows significant narrowing (more than 30%) in more than one artery.
  • People who have had a previous or recurring heart attack.
  • People with a specific inherited condition that causes very high fat (triglyceride) levels in the blood, known as type 1 hyperchylomicronemia.
  • People who developed severe acute heart failure (classified as stage III or IV) before being enrolled in the study.
  • People with a known intolerance or allergy to statin medications or ezetimibe.
  • People with heart conditions that are present from birth or developed later in life (congenital or acquired heart disease).
  • People with other serious medical conditions that are currently not well controlled (in a state of decompensation).
  • People whose heart does not beat in a normal rhythm, or who have an artificial pacemaker fitted.
  • People with certain types of heart electrical conduction problems (sinoatrial or atrioventricular block, grade 2 or 3).
  • People whose heart electrical signal (QRS complex on an ECG) lasts longer than 100 milliseconds (confirm with trial site).
  • People whose heart ultrasound shows severe thickening of the heart's left pumping chamber wall.
  • People with very high blood pressure that is not controlled (top number above 180 mmHg or bottom number above 110 mmHg).
  • People with type 1 or type 2 diabetes.
  • People with severe anaemia, meaning their haemoglobin blood level is below 100 g/L.
  • People with significant kidney disease where the kidneys are not filtering blood well enough (confirm with trial site).
  • People with an untreated thyroid condition causing an overactive or underactive thyroid.
  • People with a body mass index (BMI) of 35 or above.
  • People who are pregnant or breastfeeding.
  • People with alcohol dependency or drug addiction.
  • People with other serious health conditions that would prevent safe participation in the study.
  • People who have taken part in another clinical trial within the past two months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Valentin E Oleynikov, DM, Penza State University

Phone: +78412548229

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Penza State University
Registry
ClinicalTrials.gov
Start date
12 February 2020
Est. completion
12 November 2027

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Ventricular arrhythmias; Systolic function; Myocardial deformation of the LA and LV; PCI / CABG for a new case of coronary atherosclerosis, hospitalization for unstable angina; Myocardial electrical instability; Heart rate turbulence

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov