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 groupsLocations
51Southwest Hospital, Chongqing, China400038, ChongqingChongqing Municipality, China
Wuchang People's Hospital150200, HarbinHeilongjiang, China
Shenqiu County People's Hospital466300, ZhoukouHenan, China
Anshan Changda Hospital Anshan China
Sponsors and collaborators
Southwest Hospital, China
Lead sponsor
Source ClinicalTrials.gov