Imaging-based Thrombolysis trial in Acute Ischemic Stroke-II "ITAIS-II"

Recruiting

Phase N/A Results N/A

Trial Description

To extend the time window for thrombolysis with recombinant tissue Plasminogen Activator (rtPA) in acute ischemic stroke patients, the most significant imaging for selecting patients to implement rt-PA thrombolysis is multi-Computerised Tomography (CT) which includes Non-Enhanced CT (NECT), Computed Tomography Angiography (CTA) and CT Perfusion (CTP), or multi-MR which includes Magnetic Resonance Angiography (MRA), Diffusion-Weighted Imaging (DWI) and Perfusion-Weighted Imaging (PWI). But CT is not only more universal but also cheaper and time-saving than MR. The objective of this trial is to investigate: 1. For the selected acute ischemic stroke patients with CTP/CTA-Source Images (CTA-SI) mismatch in 3-9 hr time-window, whether the efficacy and safety of IntraVenous (IV) thrombolysis are equivalent with the routine and the classical National Institute of Neurological Disorders and Stroke (NINDS) trial which were in 3 hr time-window 2. Whether m-CT in super-early stage of stroke can predict the outcome of the patient and the efficacy of thrombolysis 3. Whether the improvement of m-CT imaging can be a substitutive indication to evaluate the outcome, and whether there is a significant correlation between the improvement and the clinical outcome

Interventions

Trial Design

Prospective, multicenter, randomized, open, assessor-blind study

Patient Involvement

In all trial centers, consecutive acute ischemic stroke patients within 9 hr time-window will be screened, and those within 3-9 hr time-window must undergo mCT examination. All patients who meet the inclusion criteria will be included in this trial and will be treated by rt-PA 0.9 mg/kg (IV) thrombolysis. 10% of the total dose will be given as a bolus in 1 minute, and the remaining will be given as an infusion over 1 hr. All participants will be divided into 3hr time-window group and 3-9 hr time-window group.

Outcomes

Type Measure Time Frame Safety Issue
Primary 1. Reperfusion improvement was assessed 24 to 48 hours post-treatment and defined as either greater than or equal to 30% reduction of Mean Transit Time (MTT) volume of abnormality or greater than or equal to 2 points improvement on the TICI grading scheme 2. Good clinical outcome at 90 days defined as a modified Rankin Score (mRS) of 0-1 3. Intracerebral haemorrhage within 24-36 h after thrombolysis
Secondary Proportion of participants who achieve the following: 1. mRS 0 to 2 at 90 days 2. Barthel Index (BI) score of 75 to 100 at 90 days 3. NIHSS 4 points improvement or 0-1 at 2 hours after treatment 4. NIHSS 4 points improvement or 0-1 at 24 to 48 hours 5. NIHSS 4 points improvement or 0-1 at day 7

Sponsors

Beijing Tiantan Hospital