Zalunfiban for Heart Attack

(CELEBRATE Trial)

Recruiting at 46 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

2499 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either zalunfiban Dose 1 (0.110 mg/kg) or zalunfiban Dose 2 (0.130 mg/kg) or placebo

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.

What data supports the effectiveness of the drug zalunfiban for heart attack?

Zalunfiban, a drug given before hospital treatment, has shown to quickly and strongly stop platelets from clumping together, which is important in treating heart attacks. It has been found to be more effective than some other drugs in reducing blood clots, especially in the early stages of a heart attack. ^{1 2 3 4 5}

How is the drug zalunfiban unique for treating heart attacks?

Zalunfiban is unique because it is a glycoprotein IIb/IIIa inhibitor that is administered subcutaneously (under the skin) and designed for prehospital use, allowing it to quickly inhibit platelets and potentially improve blood flow in heart attack patients before they reach the hospital. This rapid action distinguishes it from oral P2Y12 inhibitors, which have not shown the same effectiveness in prehospital settings. ^{1 2 3 5 6}

Research Team

Prof. Arnoud WJ Van 't Hof, MD PhD

Principal Investigator

Maastricht University Medical Center

Eligibility Criteria

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.

I am a man over 18, a woman over 50, or over 55 if participating in the Czech Republic.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of the effects of the GPIIb-IIIa antagonist Zalunfiban and the P2Y12 antagonist Selatogrel on Platelet Aggregation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prepercutaneous coronary intervention Zalunfiban dose-response relationship to target vessel blood flow at initial angiogram in st-elevation myocardial infarction - A post hoc analysis of the cel-02 phase IIa study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Prehospital treatment with zalunfiban (RUC-4) in patients with ST- elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the CELEBRATE trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tirofiban as adjunctive therapy for patients with ST-elevation myocardial infarction: a comparison versus placebo and abciximab. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Tirofiban for the treatment of ischaemic stroke. [2019]