Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals

• Status: Completed
• Trial end date: 2019-10-26
• Target enrollment: 0
• Participant gender: All

Summary

Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior circulation large vessel occlusion (LVO). Despite recanalization, a considerable proportion of patients do not recover. The incidence of symptomatic intracerebral hemorrhage (sICH) was similar between combined IVT plus MT and IVT, suggesting that this complication could not be attributed to the MT, but rather to pre-treatment with IVT. Meanwhile, the incidence of intracranial atherosclerosis stenosis (ICAS) is higher in Asians. It is not clear whether patients with ICAS benefit from pretreatment with alteplase or not and how ICAS modifies treatment effect.

Objective: To assess whether direct MT is non-inferior compared to combined IVT plus MT in patients with AIS due to an anterior circulation LVO, and to assess treatment effect modification by presence of ICAD.

Study design: This is a parallel group, RCT of direct MT compared to combined IVT plus MT, using a non-inferiority design. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up. The trial will be executed in collaboration with MRCLEAN NO-IV investigators.

Study population: Patients with AIS of anterior circulation VLO confirmed by CTA. Initiation of IVT must be feasible within 4.5 hours from symptom onset. Age must be 18 or over and NIHSS 2 or more.

Main outcomes: The full distribution of the mRS at 3 months. Secondary outcomes: 1. death within 90 +/- 14 days; 2. pre-interventional reperfusion assessed on first intracranial DSA;

3. eTICI19 score on final angiography of MT; 4. score on the NIHSS at 24 +/- 6 hours and 5-7 days, or at discharge; 5. recanalization rate at 24-72h by CTA; 6. Final lesion volume at 5-7 days on NCCT20; 7. score on the EuroQoL 5-dimensions 5-level (EQ5D-5L)21 and Barthel index22 at 90 +/- 14 days; 8. dichotomous clinical outcome on the mRS at 90 +/- 14 days.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Collaborators: Academic Medical Center Amsterdam of Netherlands; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Cardiovascular Chinese Research Center; National Health and Family Planning Commission, P.R.China; Wu Jieping Medical Foundation

Criteria

Inclusion Criteria:

• a clinical diagnosis of acute ischemic stroke,

• caused by a large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle M1/proximal M2) cerebral artery confirmed by CTA,

• CT or MRI ruling out intracranial hemorrhage,

• eligible for IVT and IAT (within 4.5 hours after symptom onset),

• a score of at least 2 on the NIH Stroke Scale,

• age of 18 years or older,

• written informed consent.

Exclusion Criteria:

• - Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2

• Any contra-indication for IVT, according to guidelines of the American Heart Association, i.e.:

• arterial blood pressure exceeding 185/110 mmHg

• blood glucose less than 2.7 or over 22.2 mmol/L

• cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging

• serious head trauma in the previous 3 months

• major surgery or serious trauma in the previous 2 weeks

• gastrointestinal or urinary tract hemorrhage in the previous 3 weeks

• previous intracerebral hemorrhage

• use of anticoagulant with INR exceeding 1.7

• known thrombocyte count less than 100 x 109/L

• treatment with direct thrombin or factor X inhibitors

• treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.