Zalunfiban for Heart Attack

(CELEBRATE Trial)

Not currently recruiting at 51 trial locations

Overseen By Robert S Hillman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CeleCor Therapeutics

Must not be taking: Anticoagulants, Thrombolytics

Disqualifiers: CPR, Dialysis, Stroke, Anemia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 31

Duration: Single administration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called zalunfiban for individuals experiencing a severe heart attack known as STEMI, which causes intense chest pain and specific changes on an ECG (a heart test). Participants will receive a single injection of either one of two doses of zalunfiban or a placebo while being transported to the hospital. Suitable candidates have experienced intense chest pain for less than four hours and have not undergone CPR or recent major surgery. The trial aims to determine if zalunfiban can improve outcomes during these critical early moments of a heart attack. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially life-saving treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically oral anticoagulants (blood thinners) and thrombolytic agents. If you are on these medications, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that zalunfiban is generally safe for people. Studies have found that it meets key safety goals, indicating it is usually safe to use. Reports show that severe or life-threatening bleeding—a major concern with heart treatments—was uncommon with zalunfiban. This finding reassures those considering joining a trial. As always, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for heart attacks, which typically involves medications like aspirin, beta-blockers, and thrombolytics, zalunfiban is unique because it is administered as a quick subcutaneous injection right in the ambulance. This novel delivery method means that treatment can begin immediately after a STEMI diagnosis, potentially improving outcomes by speeding up intervention. Furthermore, zalunfiban acts as a potent platelet aggregation inhibitor, which could offer enhanced protection against clot formation compared to current options. Researchers are excited about its potential to reduce heart damage and improve recovery times, offering a faster, more efficient approach to heart attack treatment.

What evidence suggests that zalunfiban might be an effective treatment for heart attack?

Research has shown that zalunfiban may help treat heart attacks, particularly a severe type called STEMI. An earlier study found that zalunfiban quickly and effectively stops platelets from forming clots. Another study showed that higher doses of zalunfiban were linked to fewer blood clots during initial heart procedures. Recent research reported that zalunfiban is safe and effective. This trial will test two different doses of zalunfiban, and these findings suggest that zalunfiban could effectively reduce complications in STEMI patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Prof. Arnoud WJ Van 't Hof, MD PhD

Principal Investigator

Maastricht University Medical Center

Are You a Good Fit for This Trial?

This trial is for men over 18 and post-menopausal or surgically sterile women over 50, with a weight between 52-130 kg. Participants must have had a heart attack (STEMI) with chest pain and specific ECG changes, but symptoms should not exceed four hours. They need to be able to consent to the study unless emergency conditions apply.

Inclusion Criteria

I am willing and able to give my consent for the trial, verbally or in writing, as soon as possible.

I had a severe heart attack with specific ECG changes and chest pain lasting more than 10 minutes but not over 4 hours.

Weight (by history) between 52 and 130 kg

Exclusion Criteria

I have not had major surgery, significant injury, or bleeding that required hospitalization in the last month.

I do not have an active COVID-19 infection.

I have had a stroke before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Immediate

Ambulance screening

Treatment

Participants receive a single subcutaneous injection of zalunfiban or placebo in the ambulance

Single administration

1 visit (in-person, ambulance)

Hospitalization and Initial Follow-up

Participants undergo angiography and intervention, with monitoring and blood sample collection

Up to 72 hours post-PCI/angiography

Hospital stay

Follow-up

Participants are monitored for safety and effectiveness, with follow-up phone contacts at 30 days and 12 months

12 months

Phone contacts at 30 days and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RUC-4
• zalunfiban

Trial Overview The study tests zalunfiban in patients who've just had a severe type of heart attack (STEMI). It's blinded and randomized: participants get either zalunfiban at one of two doses or a placebo by injection in an ambulance on the way to the hospital.

How Is the Trial Designed?

Group I: zalunfiban Dose 2 (0.130 mg/kg) Experimental Treatment 1 Intervention

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Group II: zalunfiban Dose 1 (0.110 mg/kg) Experimental Treatment 1 Intervention

Subjects will receive a single subcutaneous injection containing zalunfiban Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival

Group III: Placebo Placebo Group 1 Intervention

Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival

Who Is Running the Clinical Trial?

CeleCor Therapeutics

Lead Sponsor

Trials

3

Recruited

2,600+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002870322003362

Trial Designs Prehospital treatment with zalunfiban (RUC-4 ... The primary efficacy outcome is a ranked 7-point scale on clinical outcomes. The primary safety outcome is severe or life-threatening bleeding according to the ...

2. tctmd.com tctmd.com/news/celebrate-prehospital-platelet-inhibitor-zalunfiban-hits-mark-stemi

Prehospital Platelet Inhibitor Zalunfiban Hits Mark in STEMI An earlier phase IIa study, reported by TCTMD, showed that treatment with zalunfiban results in rapid and potent platelet inhibition in STEMI ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10630984/

Prepercutaneous coronary intervention Zalunfiban dose ... Our results corroborate these findings with zalunfiban and show that higher doses of zalunfiban were associated with lower thrombus burden at initial angiogram ...

4. celecor.com celecor.com/phase-3-study-of-novel-anti-platelet-drug-for-heart-attack-reports-positive-topline-results/

Phase 3 Study of Novel Anti-Platelet Drug for Heart Attack ... ... (zalunfiban) has shown positive primary efficacy and primary safety outcomes. The full results from the CeleBrate study will be released on Nov.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04825743

NCT04825743 | A Phase 3 Study of Zalunfiban in Subjects ... A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single SQ injection of ...