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

Active, not recruiting

Phase N/A Results N/A

Trial Description

1. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, whether the IntraVenous (IV) thrombolysis can improve the clinical outcome if the mismatch exists on CTP/Computed Tomography Angiography-Source Images (CTA-SI) scan in 3-9 hr time-window 2. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, whether the IV thrombolysis can improve the blood perfusion of brain if the mismatch exists on CT perfusion (CTP)/CTA-SI scan in 3-9 hr time-window 3. For the selected acute ischemic stroke patients without large vessels occlusion or significant stenosis, but the mismatch exists on CTP/CTA-SI scan in 3-9 hr time-window, whether the safety of IV thrombolysis is better than the NINDS trial which was in 3 hr window or implemented on the patients with large vessels occlusion or significant stenosis in 3-9 hr time-window.

Interventions

  • Alteplase Drug
    Intervention Desc: IV
  • NeuroAid Drug
    Other Names: Danqi Piantan Jiaonang (In China)
    Intervention Desc: Preparation containing a mixture of 14 herbal and natural extracts. A Traditional Chinese Medicine drug approved and marketed in China for "functional and neurological deficits from cerebral infarction.

Trial Design

A prospective, multi-center, assessor-blind controlled trial

Patient Involvement

Patients included were divided into recombinant tissue Plasminogen Activator (rt-PA) (0.9 mg/kg) intravenous thrombolysis group and regular treatment group according to the intention of doctors and patients.

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of participants who achieve the following: reperfusion improvement, 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; good clinical outcome at 90 days defined as a modified Rankin score (mRS) of 0-1; intracerebral haemorrhage within 24-36 h after thrombolysis.
Secondary Proportion of participants who achieve the following: mRS 0 to 2 at 90 days; Barthel Index (BI) score 75 to 100 at 90 days; NIHSS 4 points improvement or 0-1 at 2 hours after treatment; NIHSS 4 points improvement or 0-1 at 24 to 48 hours; NIHSS 4 points improvement or 0-1 at day 7.

Sponsors

The Ministry of Science and Technology and the Ministry of Health of the People's Republic of China - the key scientific research program of the 11th National Five-Year Planning of China; Beijing Tiantan Hospital (China)