2025-522542-40-00招募中3 期
TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i.v. tenecteplase vs standard of care in patients with acute ischemic stroke (including wake-up stroke), last known well >4.5 h with imaging evidence of salvageable ischemic tissue
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 71
- 主要终点
- mRS 0-1 at Day 90
研究概览
简要总结
The primary objective of the study is to test the hypothesis that i.v. tenecteplase (0.25 mg/kg, maximum 25 mg) is superior to SOC in achieving excellent functional outcome (modified Rankin Scale (mRS) score of 0-1 at Day 90) in AIS patients who were last known well >4.5 hours before randomisation (including strokes of known and unknown onset, to which wake-up strokes belong) and presenting with a significant volume of salvageable brain tissue on imaging.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.
- •Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation
- •Pre-stroke mRS ≤1 (to be assessed via medical history)
- •Imaging eligibility by MRI CT
排除标准
- •Intention to proceed to MT at the same site (hospital) of randomisation.
- •Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.
- •Contra-indications to Tenecteplase
- •Occlusion of the internal carotid artery (ICA)
- •High-risk patients (increased risk of thrombolysis related hemorrhage)
- •Any intracranial hemorrhage detected on NCCT or MRI scans
- •Contra-indication to contrast brain imaging with CT and MRI
- •Severe stroke as assessed clinically (NIHSS > 25)
- •Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator
- •Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h
- •Patients scheduled to receive i.v. thrombolysis as standard of care
研究组 & 干预措施
Metalyse 5 000 units (25 mg) powder for solution for injection
Test
干预措施: Metalyse 5 000 units (25 mg) powder for solution for injection (Drug)
结局指标
主要结局
mRS 0-1 at Day 90
mRS 0-1 at Day 90
次要结局
- mRS 0-2 at Day 90
- mRS (ordinal) at Day 90
- Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1)
- sICH as defined by SITS-MOST criteria at 36 h
- sICH as defined by ECASS III criteria at 36 h
- Death from any cause within 90 days
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (71)
Loading locations...
相似试验
尚未招募
3 期
A STUDY ON ISCHEMIC STROKE PATIENTS COMPARING THE EFFECTIVENESS OF TWO MEDICINES- TENECTEPLASE AND ALTEPLASE IN DISSOLVING BLOOD CLOTSCTRI/2024/11/077319AIIMS JODHPUR62
招募中
3 期
Thrombolysis with Tenecteplase for Acute Ischemic Stroke in Patients taking Direct Oral Anticoagulants2025-521762-99-00University Medical Center Hamburg-Eppendorf668
尚未招募
3 期
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.NCT07465718Orphalan38
已完成
1 期
The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.PRPNCT07456215Aristotle University Of Thessaloniki40
招募中
3 期
Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion StrokeNCT07357987Beijing Tiantan Hospital488