Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients
ConditionAcute Ischemic Stroke Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorSouthwest Hospital, China
About this trial
The DATE-AGING study is a prospective, multicenter, randomized controlled trial investigating low-dose tenecteplase in elderly patients with acute ischemic stroke. Its primary objective is to evaluate the safety and efficacy of low-dose tenecteplase in elderly patients within 4.5 hours of acute ischemic stroke onset.
Eligibility criteria
Qualifiers
Age ≥ 70 years;
Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (1≤ NIHSS ≤25); if NIHSS <4, patients have to be with at least a measurable deficit on motor power (upper or lower limbs ≥1);
Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation;
Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset;
Disqualifiers
Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere);
Acute bleeding diathesis or allergy to tenecteplase, including but not limited to
Known genetic predisposition to bleeding or significant bleeding disorder at present or within the past 6 Month(s) (m)
Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement
Trial design
Treatments tested in this trial
- low-dose tenecteplase intravenous thrombolysis
- standard-dose tenecteplase intravenous thrombolysis
Treatment groups
798 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov