Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 860
• Participant gender: All

Summary

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous ICH within a time window and subgroup of patients that is most likely to benefit. Our central hypothesis is that rFVIIa, administered within 120 minutes from onset with an identified subgroup of subjects most likely to benefit, will improve outcomes at 90 days as measured by the modified Rankin score (mRS) and decrease ongoing bleeding as compared to standard therapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Broderick, MD
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Novo Nordisk A/S

Criteria

Inclusion Criteria:

1. ICH patients aged 18-80 years with spontaneous ICH

2. Able to treat with rFVIIa within 120 minutes of stroke onset or last known well

3. Efforts to obtain informed consent per EFIC guidelines

Exclusion Criteria:

1. Score of 3 to 7 on the Glasgow Coma Scale (indicating deep coma).

2. Secondary ICH related known causes (e.g. trauma, aneurysm, AVM, current oral anticoagulant use, coagulopathy, etc.)

3. ICH volume < 2 cc and ≥ 60 cc

4. IVH score > 7

5. Pre-existing disability (mRS > 2)

6. Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g. cerebral infarction/ischemic stroke, 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 / μl)

11. Unfractionated heparin use with abnormal PTT

12. Low-molecular weight heparin use within the previous 24 hours.

13. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting

14. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered.

15. 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.

16. Planned withdrawal of care or comfort care measures

17. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency or psychological disorder).

18. Known or suspected allergy to trial medication(s), excipients, or related products

19. Contraindications to study medication.

20. Previous randomization in this trial.

21. Known or suspected pregnancy.