A Phase 2B Study of RUC-4 in Subjects With ST-elevation MI

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2B 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 highly trained paramedics who transport the subjects to the participating hospitals in the Netherlands and the Czech Republic. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either RUC-4 Dose 1 (0.110 mg/kg) or RUC-4 Dose 2 (0.130 mg/kg) or placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CeleCor Therapeutics

Criteria

Inclusion Criteria:

1. Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years.

2. Weight (by history) between 52 and 130 kg.

3. Subjects with STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is anticipated to be within 4 hours.

4. Verbal witnessed/short written informed consent will be obtained in the acute phase by highly trained paramedics. After the PCI/angiography procedure, written informed consent will be obtained.

Exclusion Criteria:

1. Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA), except successful intervention for Ventricular Fibrillation (VF).

2. Presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute (bpm).

3. Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).

4. Currently treated with renal dialysis.

5. Current treatment with oral anticoagulation (Vitamin K antagonists [VKA] or direct oral anticoagulants [DOACs]).

6. Major surgery, or trauma or bleeding leading to hospitalization, within the past month.

7. Known history of ischemic or hemorrhagic stroke.

8. Known severe anemia (regular blood transfusion needed).

9. Participation in another clinical study with an investigational product or device within the past month.

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