Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT04284995
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593083', 'term': 'RUC-4 compound'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-02-22', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet Inhibition', 'timeFrame': 'Baseline', 'description': 'Inhibition of Platelet Aggregation'}, {'measure': 'Platelet Inhibition', 'timeFrame': '15 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'Platelet inhibition', 'timeFrame': '45 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'Platelet inhibition', 'timeFrame': '60 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'Platelet inhibition', 'timeFrame': '90 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'Platelet inhibition', 'timeFrame': '120 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'Platelet inhibition', 'timeFrame': '180 minutes', 'description': 'Inhibition of Platelet aggregation'}, {'measure': 'RUC-4 Concentration', 'timeFrame': 'Baseline', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '15 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '45 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '90 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '120 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '180 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'Baseline', 'description': 'Bleeding events, Injection site reactions,vital signs, ECG, laboratory results'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'Hospital discharge', 'description': 'Bleeding events, Injection site reactions,vital signs, ECG, laboratory results'}, {'measure': 'RUC-4 Concentration', 'timeFrame': '240 minutes', 'description': 'concentration in blood (ng/mL)'}, {'measure': 'Platelet aggregation', 'timeFrame': '240 minutes', 'description': 'Inhibition of platelet aggregation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Disease', 'Myocardial Infarction', 'Heart Diseases', 'Vascular Diseases', 'STEMI - ST Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. This study is designed to extend the findings in CEL-01 to patients with ST-elevation myocardial Infarction (STEMI) presenting to the cardiac catheterization laboratory with planned coronary angioplasty.', 'detailedDescription': 'RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. For patients with ST-elevation myocardial infarction (STEMI) early treatment with RUC-4 could be beneficial by improving initial patency of the infarct related vessel and by minimizing thrombotic occlusions, thus improving both coronary artery and myocardial microvascular blood flow, possibly resulting in a decrease in infarct size and a reduction in complications of STEMI.\n\nThe purpose of this study is to assess the PD and PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the cardiac catheterization laboratory with planned coronary angioplasty. In addition the safety and tolerability will be assessed at baseline and hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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 symptoms to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours\n2. Adult males and females 18 years of age or older\n3. Females must be non-pregnant, non-lactating, and of non-childbearing potential (postmenopausal or surgically sterilized) by history and review of medical record\n4. Weight (by history) of between 52 and 120 kg\n5. Written informed consent (following short-form of the informed consent form at Cardiac Catheterization Lab)\n\nExclusion Criteria:\n\n1. 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\n2. High suspicion of type II MI\n3. Out of hospital cardiac arrest (OHCA)\n4. Therapy resistant cardiogenic shock (systolic blood pressure ≤80 mm Hg for \\>30 minutes)\n5. Persistent severe hypertension (systolic blood pressure \\>180 mm Hg or diastolic blood pressure \\>110 mm Hg)\n6. Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines)\n7. Known severe liver disease\n8. Known history of severe renal dysfunction (glomerular filtration rate \\<30 mL/min or serum creatinine \\>200 mmol/L \\[\\>2.5 mg/dL\\])\n9. Known left bundle branch block\n10. Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct oral antagonists {DOACs})\n11. Current treatment with αIIbβ3 receptor antagonist (other than RUC-4)\n12. Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke within the past 6 months\n13. History of upper or lower GI bleeding within the past 6 months\n14. Known clinically important anemia\n15. Known clinically important thrombocytopenia (platelet count of less than 150,000/μL)\n16. Known history of allergy to any of the ingredients in the RUC-4 formulation (i.e., acetate buffer, sucrose)\n17. Major surgery within the past 6 months\n18. Life expectancy of less than 6 months\n19. Any clinically significant abnormality identified prior to enrollment that in the judgment of the Investigator would preclude safe completion of the study\n20. 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"}, 'identificationModule': {'nctId': 'NCT04284995', 'acronym': 'CEL-02', 'briefTitle': 'A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'CeleCor Therapeutics'}, 'officialTitle': 'A Phase 2 Open Label Study to Assess the PK and PD Properties of a Single Subcutaneous Injection of RUC-4 in Patients With a ST-elevation Myocardial Infarction Presenting to the Cardiac Catheterization Lab With Planned Primary Coronary Angioplasty', 'orgStudyIdInfo': {'id': 'CEL-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1: 0.075 mg/kg RUC-4. 8 STEMI Patients will be enrolled.', 'interventionNames': ['Drug: RUC-4 Compound']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2: Dose of RUC-4 selected by Safety Review Committee (SRC) after completion of Cohort 2 and review of data. 8 STEMI Patients will be enrolled.', 'interventionNames': ['Drug: RUC-4 Compound']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Cohort 3: Dose of RUC-4 selected by Safety Review Committee (SRC) after completion of Cohort 2 and review of data. 8 STEMI Patients will be enrolled.', 'interventionNames': ['Drug: RUC-4 Compound']}], 'interventions': [{'name': 'RUC-4 Compound', 'type': 'DRUG', 'description': 'All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3435', 'city': 'Nieuwegein', 'state': 'CM', 'country': 'Netherlands', 'facility': 'St. Antonius hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CeleCor Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'St. Antonius Hospital', 'class': 'OTHER'}, {'name': 'Diagram B.V.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}