Authorised Therapeutic confirmatory (Phase III) Acute haemorrhagic stroke

Recombinant coagulation Factor VIIa administered at the earliest time for the treatment of stroke caused by bleeding in the brain - FASTEST Trial

EU CTIS ID: 2024-517383-28-00

What this study is testing

The main objective of the FASTEST trial is to establish the first treatment for acute spontaneous bleeding into the brain (intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. Part 1: The primary specific aim is to find out if treatment with recombinant Factor VIIa (rFVIIa) within 2 hours of onset of spontaneous ICH improves functional outcome as measured by a commonly used scale for measuring the degree of disability or dependence in the daily activities (modified Rankin Scale (mRS) at 180 days, as compared to placebo. Part 2: The primary specific aim is to find out if treatment with recombinant Factor VIIa (rFVIIa) within 2 hours of onset of spontaneous ICH and a positive spot sign in routine baseline CTA or treated within 90 minutes with or without a positive spot sign, improves functional outcome as measured by a commonly used scale for measuring the degree of disability or dependence in the daily activities (modified Rankin Scale (mRS) at 90 days, as compared to placebo.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1) Patients aged 18-80 years, inclusive 2) Patients with spontaneous ICH (intracerebral hemorrhage) 3) Able to treat with study medication (rFVIIa/placebo) within 2 hours of stroke onset or last known well 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. 5) Efforts 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)

You likely can't join if

  • 1) Score of 3 to 7 on the Glasgow Coma Scale 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.) 3) ICH volume < 2 ml or ≥ 60 ml 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 5) Pre-existing disability (mRS > 2) 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) 7) Clinical findings or EKG evidence of ST segment elevation consistent with acute myocardial ischemia 8) Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled) 9) Refusal to participate in study by patient, legal representative, or family member 10) Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL) 11) Unfractionated heparin use with abnormal PTT 12) Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid) 13) Low-molecular weight heparin use within the previous 24 hours 14) Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting 15) Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered 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 17) Planned withdrawal of care or comfort care measures 18) Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism,drug dependency, or psychological disorder) 19) Known or suspected allergy to trial medication(s), excipients, or related products 20) Contraindications to study medication 21) Previous participation in this trial (previously randomized) 22) Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Canada
  • United States
  • Australia
  • Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Canada; United States; Australia; Japan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.