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Clinical trialNCT07227246RecruitingPhase 3Interventional

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

SponsorJoseph Broderick, MDEnrollment350Intracerebral Hemorrhage
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients 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. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

89 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, Canada

    Recruiting
  • University of Alberta Hospital

    Edmonton, Alberta, Canada

    Recruiting
  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

    Recruiting
  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, Canada

    Recruiting
  • Hamilton General Hospital

    Hamilton, Ontario, Canada

    Recruiting
  • Ottawa Hospital Research Institute

    Ottawa, Ontario, Canada

    Recruiting
  • St. Michaels Hospital

    Toronto, Ontario, Canada

    Recruiting
  • Sunnybrook Health Sciences Center

    Toronto, Ontario, Canada

    Recruiting
  • University of Montreal Hospital

    Montreal, Quebec, Canada

    Recruiting
Germany
  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, Germany

    Recruiting
  • University Hospital Erlangen

    Erlangen, Bavaria, Germany

    Recruiting
  • Clinic Frankfurt Hoechst

    Frankfurt am Main, Hesse, Germany

    Recruiting
  • University Hospital Augsburg

    Augsburg, Germany

    Recruiting
  • Charite University Medicine Berlin

    Berlin, Germany

    Recruiting
  • University Medical Center Hamburg

    Hamburg, Germany

    Recruiting
  • University Hospital Tuebingen

    Tübingen, Germany

    Recruiting
Japan
  • National Cerebral and Cardiovascular Center

    Suita, Osaka, Japan

    Recruiting
  • Kyushu Medical Center

    Fukuoka, Japan

    Recruiting
  • Gifu University Hospital

    Gifu, Japan

    Recruiting
  • Kagoshima City Hospital

    Kagoshima, Japan

    Recruiting
  • Kobe City Medical Center General Hospital

    Kobe, Japan

    Recruiting
  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, Japan

    Recruiting
  • Niigata City General Hospital

    Niigata, Japan

    Recruiting
  • Kmu University Hospital

    Osaka, Japan

    Recruiting
  • Nho Osaka National Hospital

    Osaka, Japan

    Recruiting
  • Nakamura Memorial Hospital

    Sapporo, Japan

    Recruiting
  • Jichi Medical University Hospital

    Shimotsuke, Japan

    Recruiting
  • Kyorin University Hospital

    Tokyo, Japan

    Recruiting
  • Toranomon Hospital

    Tokyo, Japan

    Recruiting
Spain
  • Hospital Universitari Germans Trias I Pujol

    Badalona, Barcelona, Spain

    Recruiting
  • Vall D'Hebron University Hospital (vhuh)

    Horta, Barcelona, Spain

    Recruiting
  • Bellvitge University Hospital,

    L'Hospitalet de Llobregat, Barcelona, Spain

    Recruiting
  • Santa Creu and Sant Pau Hospital

    Barcelona, Catalonia, Spain

    Recruiting
  • Girona University Hospital

    Girona, Catalonia, Spain

    Recruiting
  • Arnau de Vilanova University Hospital

    Lleida, Catalonia, Spain

    Recruiting
  • Valladolid University Hospital

    Valladolid, Spain

    Recruiting
United Kingdom
  • John Radcliffe Hospital

    Oxford, Oxfordshire, United Kingdom

    Recruiting
  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, United Kingdom

    Recruiting
  • Royal Victoria Infirmary

    Newcastle upon Tyne, United Kingdom

    Recruiting
  • Queens Medical Centre

    Nottingham, United Kingdom

    Recruiting
49 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Biological/Vaccine: PlaceboFactor VIIa
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 May 2025
Primary completion
31 Jan 2029
Completion
30 Jun 2029
Last update posted
20 Aug 2026
Registered enrollment
350
Registry id
NCT07227246
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.