Ranolazine to prevent coronary microvascular damage after STEMI in people with multivessel coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase IIb/III multicenter, randomized (1:1), open-label, no-profit trial comparing ranolazine versus usual care in patients presenting with STEMI and at least one angiographically significant non-culprit stenosis. Consecutive adults undergoing successful primary PCI with a residual non-culprit lesion >50% will be enrolled and randomized to receive ranolazine or control. The primary endpoint is the relative change in Index of Microcirculatory Resistance (IMR) or angiography-derived angioIMR measured at baseline (after culprit revascularization) and again at the time of staged non-culprit PCI (either 5±2 days or within 6±2 weeks). Secondary objectives include rates and extent of coronary microvascular dysfunction and measures of recurrent ischemia.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Age ≥ 18 years and \< 80 years on day of signing informed consent
2. Ability to provide written informed consent in a time window 0 to 1 day after successful pPCI
3. ST-Elevation Myocardial Infarction at the time of the index hospitalization.
4. Successful pPCI (Thrombolysis In Myocardial Infarction \[TIMI\] flow 3 and residual coronary stenosis \<30%)
5. Presence of at least one remaining angiographically significant (% diameter stenosis \> 50%) non-culprit stenosis treatable with PCI
6. Evidence of post-menopausal status or negative urinary or serum pregnancy test for child-bearing potential patients (definitions reported in section 10.9)
7. Agreement for child-bearing potential patients who are sexually active to use contraception (definitions reported in section 10.10)

Exclusion Criteria:

1. Hemodynamically unstable patients
2. Previous myocardial infarction
3. Previous coronary artery by-pass graft (CABG)
4. Female patients with a positive pregnancy test at enrollment or prior to administration of study medication.
5. Female patients who are pregnant or breastfeeding or reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Ranolazine
6. Known hypersensitivity to the active principle (Ranolazine) or any of the excipients
7. Chronic Kidney Disease Stage 4 or 5 (eGFR \< 30 mL/min/1.73 m 2)
8. Moderate to severe liver failure (Child Pugh B - C)
9. Simultaneous intake of the following classes of drugs: strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole); HIV protease inhibitors (i.e. saquinavir, indinavir, ritonavir); class Ia antiarrhythmic drugs (i.e. ajmaline, disopyramide, procainamide, quinidine ) and class III antiarrhythmic drugs except amiodarone (i.e. dofetilide, sotalol)
10. Previous participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.

Where it's running

• Department of Medical and Surgical Sciences and "Renato Dulbecco" University Hospital, "Magna Graecia" University
  Catanzaro, Italy, Italy Recruiting
• Federico II University Hospital - Division of Cardiology
  Naples, Italy Recruiting
• Department of Cardiology, Santa Maria Goretti Hospital, Latina, Italy
  Latina, Italy, Italy Not yet recruiting

Study contacts

• Study coordinator: Luigi Di Serafino, Professor
• Email: luigi.diserafino@unina.it
• Phone: +390817462235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.