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Study of ranolazine in patients with ST-elevation heart attack and multiple blocked coronary arteries to improve small blood vessel function

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with ST-Elevation Myocardial Infarction (a severe type of heart attack) who have multiple blocked heart vessels. The research aims to evaluate how effectively a medication can protect small blood vessels in the heart after a heart attack. The medication being studied is ranolazine, which is taken as prolonged-release tablets by mouth.

The study investigates how ranolazine works to block certain electrical currents in heart cells (specifically, the late sodium current) that can contribute to heart damage after a heart attack. Participants in the study will receive either the study medication or standard treatment. The medication will be given to patients after they have undergone an emergency procedure to open their blocked heart vessel.

During the study, which lasts up to 42 days, patients will take the medication daily. The maximum daily dose will be 1500 mg. Various tests will be performed to measure how well the small blood vessels in the heart are functioning, including special imaging of the heart. Patients will also complete questionnaires about their symptoms and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After experiencing a heart attack (ST-Elevation myocardial infarction) and having initial treatment, you will be evaluated for participation in the study.

    The evaluation will occur within 24 hours after your initial heart procedure (primary PCI).

    Your heart condition must include successful treatment of one blocked artery and at least one other artery with significant narrowing that requires treatment.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to either receive ranolazine medication or standard care.

    If assigned to the medication group, you will receive ranolazine orally.

  3. Step 3

    First assessment period

    Your heart function will be measured using special tests to evaluate blood flow in small heart vessels.

    A cardiac magnetic resonance (CMR) scan will be performed to assess the extent of heart muscle damage.

  4. Step 4

    Second heart procedure

    A second planned procedure will take place either 5 days (plus/minus 2 days) or 6 weeks (plus/minus 2 weeks) after your initial treatment.

    During this procedure, the remaining narrowed artery will be treated.

    Additional measurements of heart vessel function will be taken.

  5. Step 5

    Follow-up period

    Your heart function will be monitored for approximately 42 days (plus/minus 7 days) after the initial treatment.

    You will complete questionnaires about your symptoms and quality of life.

    Your blood vessel function will be assessed using a special test (EndoPAT).

Who can join the trial?

7 criteria

  • Must be between 18 and 80 years old when signing the consent form
  • Must be able to provide written informed consent within 24 hours after successful primary heart procedure
  • Must have had a ST-Elevation Myocardial Infarction (a type of severe heart attack) during the current hospital stay
  • Must have undergone a successful primary angioplasty (a procedure to open blocked heart arteries) with good blood flow restoration and less than 30% remaining narrowing
  • Must have at least one other significant narrowing (more than 50%) in another heart artery that can be treated with angioplasty
  • For women: Must either be post-menopausal or have a negative pregnancy test if able to become pregnant
  • For women who can become pregnant and are sexually active: Must agree to use contraception during the study period

Who cannot join the trial?

15 criteria

  • Previous history of heart attack or coronary artery disease
  • Known allergies to study medications
  • Severe kidney or liver problems
  • Participation in other clinical trials within the past 30 days
  • Pregnant or breastfeeding women
  • Uncontrolled high blood pressure
  • History of major bleeding disorders
  • Severe heart rhythm problems
  • Active cancer treatment
  • Inability to provide informed consent
  • History of drug or alcohol abuse within the past year
  • Life-threatening conditions other than heart disease
  • Mental conditions that could interfere with study participation
  • Use of medications that could interact with study drugs
  • History of non-compliance with medical treatments
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Investigated drugs

Since no specific medications are directly mentioned in the provided trial data, I cannot list or describe any medications. The trial appears to be about studying late sodium current inhibition in heart attack patients, but without explicit medication names in the source data, I cannot provide descriptions of specific drugs or therapies. If you have additional data that includes the specific medications used in this trial, I would be happy to format and describe them according to the requested guidelines.

What is already known about the treatment

Late sodium current inhibitors – This class of medications works by blocking the late sodium ion channels in heart muscle cells, which helps protect the heart's microvascular system during and after a heart attack (STEMI). Administered intravenously in acute hospital settings, these drugs are currently being investigated in clinical trials for their potential to improve outcomes in patients with multi-vessel coronary disease. The medication's primary mechanism involves reducing the harmful buildup of sodium and calcium in cardiac cells during ischemic conditions, potentially preserving the function of small coronary blood vessels and preventing further damage to heart tissue. Note: Since no specific medication name was provided in the source data, I've described the class of drugs being studied in this trial (late sodium current inhibitors). The description is based on the trial's objective and medical condition being investigated.

Investigated diseases

  • ST-elevation Myocardial Infarction (STEMI)

    A serious heart condition where one of the heart's major arteries becomes blocked, stopping blood flow to a portion of the heart muscle. This blockage causes damage to heart tissue due to lack of oxygen and nutrients. STEMI specifically refers to a pattern seen on an electrocardiogram (ECG) where the ST segment is elevated, indicating full-thickness heart muscle damage. The condition develops suddenly and progresses rapidly. When occurring with multivessel disease, it means that multiple coronary arteries are affected by narrowing or blockages, not just a single vessel.

  • Coronary Microvascular Dysfunction (CMD)

    A condition affecting the heart's smallest blood vessels, where these tiny arteries don't work properly or become damaged. These vessels may not dilate properly or may have irregular blood flow patterns. The condition can occur in both damaged and undamaged areas of the heart. CMD can develop gradually or appear suddenly after a heart attack.

  • Periprocedural Myocardial Infarction (PMI)

    A type of heart muscle injury that occurs as a complication during or shortly after a planned heart procedure. It involves damage to heart tissue that happens while doctors are performing interventions on the heart's blood vessels. This condition differs from a spontaneous heart attack as it is specifically related to medical procedures.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520801-12-00Protocol codeINAMICRONEstimated enrolment100 patientsSponsorUniversita' Degli Studi Di Napoli Federico II

sourced from the EU Clinical Trials Register and site verification

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