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

3 1

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
CHU Grenoble Alpes La Tronche France
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Hopital Beaujon Clichy France
Amphia Hospital Breda The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Ulwrxeswqo Oz Dtcasnyq Debrecen Hungary
Ancwdtihmm Phssjkcg Hcqbsyni Dg Maqrmebru Marseille France
Utrlkckqbofz Madxbvw Cfwakyd Uubnygw Utrecht The Netherlands
Fesitvns Ndpybzqbj Bueo Brno Czechia
Ulxoyqprco Hiwgrvox Mujftioars Maastricht The Netherlands
Cxeuqa Hevsduyuvcz Uwnyblkbeoyfy Do Ryrjyn Rennes France
Mgtbugn Sxigiznr Turlym Enschede The Netherlands
Zufnzahgee Gbvxbuzy Vdlagi Szktkqham Ede The Netherlands
Bavbxpcfyzz Vlrtbflwy Olffpquxdzoa Kecskemet Hungary
Ifgzdkykvd dy Bzeh Cfqqcvkjhdqyyum &jmaqeevrrac Dtv Gqwbvy Ivhc Ghjicpibgscqzrlf Iufs Iasi Romania
Htqckbv Evarruta db Pcdmo &hlrunl Guw Csoy &riqp Rjusuxmw Aubervilliers France
Ceciai Hestubobaou Ihezgtkq Gqgqyobr Montreuil France
Buvinak Soxrpgeavrkcirsi Pgdbw Paris France
Hiedcnt Bawthu Cwpknvfkbqkomu Anqxd Paris France
Adchtkjeny Ptertvna Haxjwbjv Da Pchdj Paris France
Hsmhsmj Abuorvti Pdqj Boulogne-Billancourt France
Fvgeszgh Nrxqblxoy U Su Araa V Bqub Brno-Stred Czechia
Sjkdugucdl Zrlqkkzkuf Doetinchem The Netherlands
Hezykrkc Fsur Suresnes France
Lssos Uscxxqctobtt Mbsgmch Cjodnkf (vtbwn Leiden The Netherlands
Rvyxzekkt Ztazfimdch Szknkhzre Arnhem The Netherlands
Iaiub Khmjtlfnn Spwuqetxw Zwolle The Netherlands
Jbwgnr Bnhjz Znzqnqvbux Svkbdpabt S-Hertogenbosch The Netherlands
Tbuzrkixvyjqdvxmppb Hilversum The Netherlands
Unxmhbvhue Hnynpcjog Pokqj Sufbajgrovb Cpjrtab Fxwp Paris France
Ipsqjgdume Db Brrd Copkewwvunwktts Tkixebugq Timisoara Romania
Sjhmngygt Vcqodtt Maolujh Cellrdz vcdf Nfegnuoapgdok Venlo The Netherlands
Eshqeyvof Iuupqtugp Fap Coikuooqbdyvkr Doulytyt Aqq Tqvqtcitar Targu Mures Romania
Eymqjwhuzfgtuvyajtnb Zxaehjozqf Tilburg The Netherlands
Inuuiycunk Dt Uappznj Pcwicw Bxrg Chzfqmxhqegjnre Panoo Dzd Cq Cx Iwfyeiz Bucharest Romania

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)

Other Trials to Consider

  • Bisoprolol in Patients After Myocardial Infarction with Preserved Ejection Fraction During Cardiac Rehabilitation

    Recruiting

    3 1 1 1
    Investigated Drugs:
    Belgium
  • A study evaluating the effect of methylprednisolone compared to sodium chloride in patients with a heart attack

    Recruiting

    3 1 1
    Denmark