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Zalunfiban

Zalunfiban is being studied in clinical trials for people with an acute heart attack, especially STEMI. The trials are designed to check whether it improves clinical outcomes and to measure bleeding safety after a single subcutaneous injection.

Table of contents

Trial overview

The clinical trial NCT04825743 is studying Zalunfiban in people with an acute heart attack called STEMI.[1] This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes.[1]

The study is authorised and plans to enroll 2564 participants.[1] It is a Phase 3 trial, which is a larger later-stage study used to test whether a treatment works and how safe it is in the target group.[1]

Who can join the study

The trial is for subjects with documented STEMI who have persistent ischemic chest pain lasting more than 10 minutes.[1] They must also have new ST-segment elevation of at least 2 mm in 2 adjacent ECG leads.[1]

The symptoms to diagnostic ECG are expected to be within 4 hours, which means the study focuses on very early treatment in an acute heart attack setting.[1]

What is being tested

Researchers are comparing a single subcutaneous injection of Zalunfiban with placebo.[1] A placebo is an inactive treatment used to help show whether the study drug makes a difference.[1]

The trial looks at the effects of this treatment in the pre-hospital setting, meaning before the patient reaches the hospital.[1]

Outcomes being measured

The main efficacy endpoint is a 7-point clinical outcome scale at 30 days after randomization.[1] This scale ranks outcomes from worst to best and includes death, stroke, recurrent myocardial infarction, acute stent thrombosis, new onset heart failure or rehospitalization for heart failure, and myocardial infarction with high-sensitivity cardiac troponin T levels at least 30 times the upper limit of normal.[1]

In simple terms, the study wants to see whether patients do better overall after treatment with Zalunfiban compared with placebo.[1]

Safety is also a key endpoint.[1] The trial measures bleeding events at 30 days using GUSTO severe or life-threatening criteria, and it also records bleeding using BARC Type 3C and 5 criteria for information.[1]

Trial design and phase

This is a Phase 3 interventional trial with randomization between Zalunfiban and placebo.[1] Randomization means participants are assigned by chance, which helps make the comparison fair.[1]

The study uses a single dose approach, given as a subcutaneous injection.[1] The follow-up period for the main outcomes is 30 days.[1]

What the results will show

This trial is designed to show whether early use of Zalunfiban can improve short-term clinical outcomes in people with STEMI.[1] It also checks whether bleeding risks are acceptable after treatment.[1]

Because the study includes patients in the pre-hospital setting, it focuses on fast treatment during the early stages of a heart attack.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04825743 Phase 3 Acute heart attack (STEMI) Authorised 2564

FAQ

  • What condition is being studied in the Zalunfiban trial? The trial is studying acute heart attack, specifically STEMI. STEMI means a type of heart attack with clear ST-segment elevation on an ECG test.
  • Who can take part in the trial? People with documented STEMI, ongoing ischemic chest pain for more than 10 minutes, and new ST-segment elevation in 2 nearby ECG leads may be eligible. The symptoms to diagnostic ECG are expected to be within 4 hours.
  • What is the main goal of the study? The main goal is to compare Zalunfiban with placebo after a single injection. The study looks at both clinical benefit and safety.
  • What phase is the Zalunfiban trial? This study is a Phase 3 trial. Phase 3 trials are larger studies that help show whether a treatment works and how safe it is in a target patient group.
  • What outcomes are being measured? The trial measures a 7-point clinical outcome scale, including death, stroke, repeat heart attack, stent thrombosis, heart failure, and severe heart injury markers. It also measures bleeding events at 30 days.

Ongoing Clinical Trials on Zalunfiban

  • Study on the Effects of Zalunfiban for Patients with ST-Elevation Myocardial Infarction (Heart Attack)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary The Netherlands Romania

Glossary

  • STEMI: A type of heart attack with a specific ECG pattern called ST-segment elevation.
  • ECG: A test that records the heart’s electrical activity.
  • Ischemic chest pain: Chest pain caused by reduced blood flow to the heart.
  • ST-segment elevation: An ECG change that can show a serious heart attack.
  • Adjacent ECG leads: Nearby recording points on an ECG test that help show where heart damage may be happening.
  • Placebo: An inactive treatment used for comparison in a trial.
  • Phase 3: A later stage of clinical research with many participants, used to test whether a treatment works and is safe.
  • Randomization: A way of assigning participants to treatment groups by chance.
  • PCI: A procedure to open a blocked heart artery, often using a stent.
  • Stent thrombosis: A blood clot that forms inside a stent.
  • Heart failure: A condition where the heart does not pump blood as well as it should.
  • GUSTO bleeding criteria: A standard way to classify serious bleeding in heart studies.

References