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New treatment option for Myocardial Infarction, Acute
Official title Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI
ClinicalTrials.gov ID: NCT04347434
What this study is testing
What is Atorvastatin 80mg?
Atorvastatin 80mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myocardial infarction, acute.
Also referred to as Ezetimibe.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70
You may be able to join if
- 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.
You likely can't join if
- Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
- Recurrent or repeated myocardial infarction.
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
- The development of acute heart failure III-IV prior to randomization
- Individual intolerance to statins, ezetimibe.
- Congenital and acquired heart diseases.
See the full eligibility criteria
- 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.
- Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
- Recurrent or repeated myocardial infarction.
- Exogenous hypertriglyceridemia (type 1 hyperchilomicronemia).
- The development of acute heart failure III-IV prior to randomization
- Individual intolerance to statins, ezetimibe.
- Congenital and acquired heart diseases.
- Severe concomitant diseases in the stage of decompensation.
- 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.
- Uncontrolled hypertension with SBP\> 180 mm Hg and DBP\> 110 mmHg
- Diabetes mellitus (DM) type 1 and 2.
- 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).
- Non-corrected thyroid dysfunction with hyper / hypothyroidism.
- Body mass index (BMI) ≥35 kg / m2.
- Pregnancy, lactation.
- Alcohol abuse, drug addiction.
- Other serious concomitant diseases that exclude the possibility of study participation.
- Participation in other clinical trials within the last two months.
The study team makes the final eligibility decision.
Where it's taking place
- Penza, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Penza, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.