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

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Zalunfiban in patients who have experienced an acute heart attack, specifically a type known as ST-elevation myocardial infarction (STEMI). STEMI is a serious condition where a part of the heart muscle is suddenly blocked from receiving blood, leading to chest pain and changes in the heart’s electrical activity. The study will compare the effects of a single injection of Zalunfiban with a placebo, which is an inactive substance, to understand its safety and effectiveness.

The purpose of the study is to assess the outcomes of patients 30 days after receiving the treatment. Participants will receive a single injection of Zalunfiban or a placebo before they reach the hospital. The study will monitor the patients for any major health events, such as death, stroke, or another heart attack, as well as any bleeding incidents, which are important safety concerns. The study aims to provide insights into how Zalunfiban might help improve the condition of patients with STEMI when administered early.

Throughout the study, patients will be observed for any side effects or reactions at the injection site. The trial will also track the patients’ recovery and any additional treatments they might need. This research is important for understanding how Zalunfiban can be used to potentially improve outcomes for people experiencing a heart attack, offering new possibilities for treatment in emergency situations.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide informed consent, which means you agree to participate after understanding the details of the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your medical history, current health status, and specific criteria related to your heart condition.

3 medication administration

You will receive a single subcutaneous injection of either zalunfiban or a placebo. This means the medication or placebo will be injected under your skin. The purpose is to evaluate the effects of the medication on your heart condition.

4 monitoring and follow-up

After the injection, your health will be monitored closely. This includes regular checks on your heart condition and any potential side effects. Monitoring will continue for up to 30 days to assess the treatment’s impact.

You will be asked to report any symptoms or changes in your health during this period.

5 final assessment

At the end of the 30-day period, a final assessment will be conducted. This will involve evaluating your overall health and the effects of the treatment on your heart condition.

The results will help determine the safety and effectiveness of the medication.

Who Can Join the Study?

  • Planned transport to a participating clinical site.
  • Males aged 18 years or older.
  • Females who are post-menopausal or surgically sterile, aged 50 years or older.
  • Weight between 52 and 130 kg (115 and 287 lb).
  • Subjects with documented presumed STEMI (a type of heart attack), presenting with persistent chest pain lasting more than 10 minutes and new ST-segment elevation of 2 mm or more in two adjacent ECG leads. The total duration of symptoms to diagnostic ECG should be a maximum of 4 hours.
  • Enrollment by a process that includes verbal or written informed consent, which means the subject agrees to participate after understanding the study. This consent can be given by the subject or a legally authorized representative.

Who Cannot Join the Study?

  • Patients who have had a recent heart attack known as STEMI (ST-Elevation Myocardial Infarction) with specific changes in their heart’s electrical activity.
  • Patients who have ongoing chest pain lasting more than 10 minutes.
  • Patients who have new changes in their heart’s electrical activity, specifically a rise of 2 mm or more in two adjacent leads on an ECG (Electrocardiogram), which is a test that measures the electrical activity of the heart.
  • Patients whose total time from the start of symptoms to the diagnostic ECG is expected to be within 4 hours.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
CHU Grenoble Alpes La Tronche France
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Hospital Foch Suresnes France
Isala Klinieken Stichting Zwolle The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Elisabeth-Tweesteden Ziekenhuis Tilburg The Netherlands
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Institutul De Boli Cardiovasculare Timisoara Timisoara Romania
Fakultni Nemocnice Brno Brno Czechia
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Hopital Ambroise Pare Boulogne-Billancourt France
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Slingeland Ziekenhuis Doetinchem The Netherlands
Centre Hospitalier Universitaire De Rennes Rennes France
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
University Of Debrecen Debrecen Hungary
Semmelweis University Budapest Hungary
Hopital Beaujon Clichy France
Tergooiziekenhuizen Hilversum The Netherlands
Likkw Ukjkabvlravf Myglnpx Cxzgvgz (hqrwr Leiden The Netherlands
Rrjjjctua Zzysnteuft Syyptyyvb Arnhem The Netherlands
Ueqlvveowa Htnpwdedr Pmtgl Sghspeiakfz Cqafhib Feml Paris France
Ivpwqlcdwj df Bbvp Cwyukndgvrobtxq &tqniijputgr Dsy Ggtybn Itov Gcnxdkqggsjnssfs Idrn Iasi Romania
Bkuasqs Slaldnbuxohrewxf Pnzgo Paris France
Cezcdw Hfbrzmaauzd Iorfdhim Gkfeamdx Montreuil France
Himcatc Bbcyte Ccjcmecrpltbii Arjmx Paris France
Hzvuhgy Etzrfkez do Pztrs &iqgrtl Gex Cumm &qgxp Rcvnzfhu Aubervilliers France
Ahhwuwzvyp Pxwtgozv Hrjqsnuj Do Piein Paris France
Alulvfhunq Pypkztwp Hrhwuhih Do Msocixflk Marseille France
Bgronxvhtar Vxpuitymf Owbhkfubqoez Kecskemet Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
24.04.2021
France France
Not recruiting
24.04.2021
Hungary Hungary
Not recruiting
24.04.2021
Romania Romania
Not recruiting
24.04.2021
The Netherlands The Netherlands
Not recruiting
24.04.2021

Trial locations

Investigated drugs:

Zalunfiban is a medication being tested in this clinical trial to see if it can help people who are having a type of heart attack called ST-elevation myocardial infarction, or STEMI. This medication is given as a single injection under the skin before the patient reaches the hospital. The goal is to see if it can improve the patient’s condition 30 days after the heart attack. The study also looks at whether the medication causes any serious bleeding problems, which is an important safety concern. By participating in this trial, researchers hope to find out if zalunfiban can be a safe and effective treatment for people experiencing this kind of heart attack.

ST-Elevation Myocardial Infarction (STEMI) – This condition occurs when a coronary artery is completely blocked, leading to a significant portion of the heart muscle being deprived of oxygen. It is characterized by persistent chest pain lasting more than 10 minutes and noticeable ST-segment elevation in at least two adjacent leads on an electrocardiogram (ECG). The blockage is usually caused by a blood clot that forms on a ruptured plaque in the artery. As the heart muscle is deprived of oxygen, it begins to suffer damage, which can worsen over time if the blockage is not resolved. The progression of the disease can lead to complications such as heart failure or arrhythmias. Immediate medical intervention is crucial to restore blood flow and minimize heart muscle damage.

Trial ID:
2023-508485-15-00
Protocol code:
CEL-03
NCT ID:
NCT04825743
Trial Phase:
Therapeutic confirmatory (Phase III)

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