A study to assess the effects of a platelet inhibitor (RUC-4). This platelet inhibitor is given by a single subcutaneous injection.Targeted patients are patients with an acute myocardial infarction. The medication will be given on the cardiac catheterization lab. Subsequently a coronary angiography will be perormed and if needed the patient will be treated with primary coronary angioplasty

Phase 1

• Conditions: Patients with STEMI, presenting with persistent chest pain (>30 min) and = 1 mm ST-segment elevation in two adjacent electrocardiograph leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours. Patients are adult males and females 18 years of age or older.; MedDRA version: 20.0Level: HLGTClassification code 10028593Term: Myocardial disordersSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10028600Term: Myocardial ischaemiaSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 21.0Level: PTClassification code 10081099Term: Acute cardiac eventSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10062084Term: Platelet aggregationSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: PTClassification code 10050661Term: Platelet aggregation inhibitionSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-004282-41-NL
• Lead Sponsor: CeleCor Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Patients with STEMI, presenting with persistent chest pain (>30 min) and = 1 mm ST-segment elevation in two adjacent ECG-leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours
- Adult males and females 18 years of age or older
- Females must be non-pregnant, non-lactating, and of non-childbearing potential (postmenopausal or surgically sterilized)
- Weight (by history) of between 52 and 120 kg
- Written informed consent (following short-form of the informed consent form at CCL)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- High probability in the opinion of the cardiologist that current STEMI is caused by stent thrombosis and the previous PCI related to this stent thrombosis is < 1 month
- Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
- High suspicion of type II MI
- Out of hospital cardiac arrest (OHCA)
- Therapy resistant cardiogenic shock (systolic blood pressure = 80 mm Hg for > 30 minutes)
- Persistent severe hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
- Known severe liver disease
- Known history of severe renal dysfunction (glomerular filtration rate < 30 mL/min or serum creatinine > 200 mmol/L [> 2.5 mg/dL])
- Known left bundle branch block
- Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct oral antagonists {DOACs})
- Chronic use of P2Y12 antagonists
- Current treatment with aIIbß3 receptor antagonist (other than RUC-4)
- Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke < 6 months
- History of upper or lower GI bleeding within the past 6 months
- Known clinically important anemia
- Known clinically important thrombocytopenia (platelet count of less than 150,000/µL)
- Known history of allergy to any of the ingredients in the RUC-4 formulation (i.e., acetate buffer, sucrose)
- Major surgery within the past 6 months
- Life expectancy of less than 6 months
- Any clinically significant abnormality identified prior to enrollment that in the judgment of the Investigator would preclude safe completion of the study
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient’s ability to comply with the study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified