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Investigation to assess the effects of zalunfiban in patients with an acute heart attack
EU CTIS ID: 2023-508485-15-00
What this study is testing
Efficacy: To assess the clinical outcome at 30-day follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in presumed STEMI subjects in the pre-hospital setting Safety: To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life-threatening criterion for safety assessment and, for information only, according to the BARC Type 3C and 5 criteria) after a single subcutaneous injection of zalunfiban versus placebo at 30-day follow-up
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Planned transport to participating clinical site.
- Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
- Weight (by history) between 52 and 130 kg (115 and 287 lb).
- Subjects with documented presumed STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum. For selected sites, the diagnostic ECG is obtained at the enrolling site. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
- Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics [according to local applicable legal regulations. This may include both ambulance and clinical site enrollment or clinical site enrollment only, with the sponsor’s approval, if more than 30 minutes of delay is anticipated for door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject’s clinical condition allows it.
You likely can't join if
- Cardiopulmonary resuscitation (CPR) for current out-of-hospital cardiac arrest (OHCA).
- Participation in another clinical study with an investigational product or device within the past month
- Life expectancy less than one year
- Cardiogenic shock, presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute.
- Current known active COVID-19 infection (criteria according to local guidelines).
- Currently treated with renal dialysis.
See the full eligibility criteria
- Planned transport to participating clinical site.
- Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
- Weight (by history) between 52 and 130 kg (115 and 287 lb).
- Subjects with documented presumed STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum. For selected sites, the diagnostic ECG is obtained at the enrolling site. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
- Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics [according to local applicable legal regulations. This may include both ambulance and clinical site enrollment or clinical site enrollment only, with the sponsor’s approval, if more than 30 minutes of delay is anticipated for door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject’s clinical condition allows it.
- Cardiopulmonary resuscitation (CPR) for current out-of-hospital cardiac arrest (OHCA).
- Participation in another clinical study with an investigational product or device within the past month
- Life expectancy less than one year
- Cardiogenic shock, presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute.
- Current known active COVID-19 infection (criteria according to local guidelines).
- Currently treated with renal dialysis.
- Current treatment with oral anticoagulation (vitamin K antagonists* [VKAs] or direct oral anticoagulants** [DOACs]) and thrombolytic agents***. For example: *acenocoumarol or phenprocoumon, fluindione, and Coumadin (warfarin) **dabigatran, apixaban, edoxaban, rivaroxaban, and betrixaban ***tenecteplase, alteplase, reteplase, streptokinase, and urokinase
- Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
- Known history of ischemic or hemorrhagic stroke
- Known severe anemia (regular blood transfusion needed)
- Previously enrolled in this study
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Mexico
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Mexico; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.