Study on the Effects of Zalunfiban for Patients with ST-Elevation Myocardial Infarction (Heart Attack)
This clinical trial is investigating the effects of Zalunfiban, a new medication for patients experiencing ST-elevation myocardial infarction (STEMI), which is a serious type of heart attack. In STEMI, a coronary artery becomes completely blocked, preventing oxygen from reaching a significant portion of the heart muscle. This can lead to severe damage if not treated quickly.
Who can participate?
The trial is looking for patients who meet the following criteria:
- Men aged 18 years or older
- Women who are 50 years or older and are either post-menopausal or surgically sterile
- Weight between 52 and 130 kg (115 to 287 pounds)
- Experiencing persistent chest pain lasting more than 10 minutes with specific changes on their heart monitoring test (ECG showing at least 2 mm ST-segment elevation in two adjacent leads)
- Time from the start of symptoms to diagnostic ECG must be within 4 hours
- Planned for transport to a participating clinical site
- Able to provide informed consent, either personally or through a legally authorized representative
Who cannot participate?
The trial excludes patients who do not meet the specific STEMI criteria outlined above, particularly those whose symptoms and ECG changes do not match the required pattern for the study, or whose time from symptom onset to ECG exceeds 4 hours.
What is the goal of the trial?
The study aims to determine whether Zalunfiban, given as a single injection under the skin before reaching the hospital, can improve outcomes for patients 30 days after their heart attack. Researchers will compare the effects of Zalunfiban with a placebo (an inactive substance) to understand its safety and effectiveness. The trial will monitor patients for major health events such as death, stroke, or another heart attack, as well as any bleeding incidents, which are important safety concerns.
What happens during the trial?
Participants will receive a single injection of either Zalunfiban or placebo under the skin. After the injection, their health will be closely monitored for up to 30 days. This includes regular checks on heart condition and any potential side effects. At the end of the 30-day period, a final assessment will evaluate overall health and the treatment's impact on the heart condition.
About the investigational drug
Zalunfiban is classified as an antiplatelet medication, which means it helps prevent blood cells called platelets from sticking together and forming clots. It works by blocking certain proteins in the blood that can cause blood clots, helping to keep blood flowing smoothly to the heart. This is particularly important during a heart attack when blood flow to the heart muscle is already compromised.