出血性脳卒中に対する遺伝子組換え因子VIIa（rFVIIa）の臨床試験 - パート2

基本情報

NCT ID

NCT07227246

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

350

治験依頼者名

University of Cincinnati

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (14)