Eptacog alfa (activated) for Intracerebral haemorrhage | Acute haemorrhagic stroke

Inclusion criteria

• {"criterion_text":"- 1) Patients aged 18-80 years, inclusive\n- 2) Patients with spontaneous ICH (intracerebral hemorrhage)\n- 3) Able to treat with study medication (rFVIIa/placebo) within 2 hours of stroke onset or last known well\n- 4) Positive spot sign on baseline CTA (Part 2 only) or able to be treated within 90 minutes with or without a positive spot sign.\n- 5)\tEfforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan, Australia, Finland)"}

Exclusion criteria

• {"criterion_text":"- 1) Score of 3 to 7 on the Glasgow Coma Scale\n- 2) Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)\n- 3) ICH volume < 2 ml or ≥ 60 ml\n- 4) Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles\n- 5) Pre-existing disability (mRS > 2)\n- 6) Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)\n- 7) Clinical findings or EKG evidence of ST segment elevation consistent with acute myocardial ischemia\n- 8) Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)\n- 9) Refusal to participate in study by patient, legal representative, or family member\n- 10) Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)\n- 11) Unfractionated heparin use with abnormal PTT\n- 12) Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)\n- 13) Low-molecular weight heparin use within the previous 24 hours\n- 14) Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting\n- 15) Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered\n- 16) Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment\n- 17) Planned withdrawal of care or comfort care measures\n- 18) Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism,drug dependency, or psychological disorder)\n- 19) Known or suspected allergy to trial medication(s), excipients, or related products\n- 20) Contraindications to study medication\n- 21) Previous participation in this trial (previously randomized)\n- 22) Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment"}

Primary endpoints

• {"endpoint_text":"- Part 1: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 180 days: 0-2, 3, and 4-6.\n- Part 2: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 90 days: 0-2, 3, and 4-6.","definition_or_measurement_approach":"Part 1 measured as the distribution of the ordinal modified Rankin Scale (mRS) at 180 days (categories 0-2, 3, 4-6). Part 2 measured as the distribution of the ordinal mRS at 90 days (categories 0-2, 3, 4-6)."}

Secondary endpoints

• {"endpoint_text":"- ordinal mRS (all seven steps)\n- routine CT\n- utility-weighted Rankin Score\n- mRS of 0-2\n- EQ-5D at 90 days and 180 days\n- the trichotomous endpoint at 180 days for Part 2\n- change in the volume of ICH and ICH-IVH between the baseline routine CT and 24-hour routine CT","definition_or_measurement_approach":"Secondary measures include the full ordinal mRS at specified timepoints, imaging-based assessments (routine CT at baseline and 24 hours to assess change in ICH and ICH-IVH volume), utility-weighted Rankin, dichotomous mRS (0-2), EQ-5D at 90 and 180 days, and a trichotomous endpoint at 180 days for Part 2."}

Germany

Earliest CTIS Part Ii Submission Date

23-08-2024

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

502

Number Of Sites

9

Number Of Participants

60

Spain

Earliest CTIS Part Ii Submission Date

23-08-2024

Latest Decision Or Authorization Date

25-09-2025

Processing Time Days

398

Number Of Sites

8

Number Of Participants

65

Primary sponsor

Full Name

University Of Cincinnati College Of Medicine

Organisation Type

Educational Institution

Country Of Registered Address

United States

Contract research organisations

Name

Clinical Research Services - Dr Diana Salein

Responsibilities

[{ "id":937647, "code":"1" }, { "id":937648, "code":"12" }]

Name

Medical University of South Carolina - NIH StrokeNet National Datamanagement Center -NDMC

Responsibilities

[{ "id":937642, "code":"10" }, { "id":937643, "code":"15", "value":"Regulatory document management/filing" }, { "id":937644, "code":"3" }, { "id":937645, "code":"6" }, { "id":937646, "code":"7" }]

Third parties

• {"country":"Germany","full_name":"Clinical Research Services - Dr Diana Salein","duties_or_roles":"[{ \"id\":937647, \"code\":\"1\" }, { \"id\":937648, \"code\":\"12\" }]","organisation_type":"SME"}
• {"country":"United States","full_name":"Medical University of South Carolina - NIH StrokeNet National Datamanagement Center -NDMC","duties_or_roles":"[{ \"id\":937642, \"code\":\"10\" }, { \"id\":937643, \"code\":\"15\", \"value\":\"Regulatory document management/filing\" }, { \"id\":937644, \"code\":\"3\" }, { \"id\":937645, \"code\":\"6\" }, { \"id\":937646, \"code\":\"7\" }]","organisation_type":"Educational Institution"}