Ischemic Stroke Clinical Trial
— DIRECT-MTOfficial title:
Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation
Verified date | October 2019 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 656 |
Est. completion date | October 26, 2019 |
Est. primary completion date | October 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | 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 |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mRS (the modified Rankin Scale) | The mRS is an ordinal hierarchical scale ranging from 0 to 5, with higher scores indicating more severe disability. | 3 months after procedure | |
Secondary | eTICI score (Extended Treatment In Cerebral Ischemia) | The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory. | Immediately after procedure | |
Secondary | NIHSS (The National Institutes of Health Stroke Scale) | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | at 24 hours and 5-7 days | |
Secondary | Recanalization rate | Recanalization rate at 24-48 hours after intra-arterial thrombectomy, assessed with CT angiography | at 24-48 hours after intra-arterial thrombectomy | |
Secondary | Final infarct volume | Final infarct volume will be assessed with the use of an automated, validated algorithm. | at 5-7 days | |
Secondary | sICH (symptomatic intracranial hemorrhage) rate | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by =4 points than the value at baseline or the lowest value in the first 7 days or any hemorrhage leading to death. | 7 days after intra-arterial thrombectomy |
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