2463 Participants Needed

Zalunfiban for Heart Attack

(CELEBRATE Trial)

Recruiting at 47 trial locations
RS
Overseen ByRobert S Hillman, PhD
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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 Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) 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.

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.12345

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.12356

Who Is on the Research Team?

PA

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.
See 8 more

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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: zalunfiban Dose 2 (0.130 mg/kg)Experimental Treatment1 Intervention
Group II: zalunfiban Dose 1 (0.110 mg/kg)Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CeleCor Therapeutics

Lead Sponsor

Trials
3
Recruited
2,600+

Citations

Comparison of the effects of the GPIIb-IIIa antagonist Zalunfiban and the P2Y12 antagonist Selatogrel on Platelet Aggregation. [2023]
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]
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]
Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. [2023]
Safety and efficacy of tirofiban as adjunctive therapy for patients with ST-elevation myocardial infarction: a comparison versus placebo and abciximab. [2019]
Tirofiban for the treatment of ischaemic stroke. [2019]
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