臨床研究等提出・公開システム

The investigator-initiated international clinical trial on efficacy and safety of recombinant factor VIIa for hyperacute intracerebral hemorrhage (FASTEST)

Recombinant factor VIIa for hyperacute intracerebral hemorrhage (FASTEST)

Toyoda Kazunori

National Cerebral and Cardiovascular Center

6-1 Kishibe-Shimmachi

toyoda@ncvc.go.jp

Hatano Megumi

National Cerebral and Cardiovascular Center

6-1 Kishibe-Shimmachi Suita Osaka

+81-6-6170-1070

hatano@ncvc.go.jp

Recruiting

Nov. 01, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Patients aged 20 to 80 years with spontaneous intracerebral hemorrhage who can be treated within 120 minutes of stroke onset or last-known-well
Part2: Patients aged 20 to 80 years with spontaneous intracerebral hemorrhage who eather (1) can be treated within 120 minutes of stroke onset or last-known-well with a positive spot sign on CTA or (2) can be treated within 90 minutes of stroke onset regardless of spot sign status.

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 cc and => 60 cc
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 or EKG evidence of ST 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/micro L)
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

Both

Spontaneous intracerebral hemorrhage

We will randomly assign patients in a 1:1 ratio to intravenous rFVIIa or placebo at a dose of 80 micro-g/kg (maximum 10,000 micro-g or 10 mg) and administered intravenously over 2 minutes. All investigators and patients will be blinded throughout the course of the study.

Primary efficacy outcome: ordinal modified Rankin Scale (mRS) at 180 days: 0-2, 3, and 4-6
Part 2: The primary outcome measure is the following distribution of the he ordinal mRS at 90 days: 0-2, 3, and 4-6.
Primary safety outcome: life-threatening thromboembolic complications (acute myocardial infarction, acute cerebral infarction, and acute pulmonary embolism) during the first four days after completion of study drug.

The ordinal mRS (all seven steps), utility-weighted Rankin Score, mRS of 0-2, and EQ-5D at 90 days and 180 days; change in the volume of intracerebral hemorrhage and (intracerebral hemorrhage + intraventricular hemorrhage) between baseline CT and 24 hour CT; mortality at 180days and mRS of 5-6 at 180 days.
Part 2: To test the hypothesis that treatment with rFVIIa within 2 hours of onset in appropriately selected patients with spontaneous ICH and a positive spot sign, improves outcome as measured by the modified Rankin Scale (mRS) at 180 days, as compared to placebo.

+81-75-753-4680

Mar. 13, 2020

Unitd States/Canada/Germany/Spain/United Kingdom/Australia/Finland