Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis.
Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear.
The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old;
Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
Residual NIHSS score > 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
Informed consent obtained from patients or an authorized representative.
Disqualifiers
Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery, intracranial/extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by vessel imaging (including computed tomography angiography [CTA] or magnetic resonance angiography [MRA]), or scheduled for endovascular treatment (including mechanical thrombectomy, intra-arterial thrombolysis, and angioplasty).
Intracranial hemorrhage confirmed by imaging post-thrombolysis.
Definite or suspected cardioembolic stroke.
Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin
DrugPatients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.
Placebo
DrugPatients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.
Best medical management
Other interventionPatients in both groups will receive the best medical management according to the guidelines.
Treatment groups
1,184 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 90-days follow up.
Time frame
Ninety days after stroke.Secondary outcomes
1
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 30-days follow up.
Time frame
Thirty days after stroke.2
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. Functional independence is defined as mRS of 0-2.
Time frame
Ninety days after stroke.3
The shift analysis in the 90-day modified Rankin scale (mRS) score.
The mRS ranges from 0 to 6, with higher scores indicating a worse outcome.
Time frame
Ninety days after stroke.4
The proportion of patients achieving neurological improvement.
Neurological improvement is defined as a decrease of ≥2 points in the NIHSS score at 48 hours of randomization compared to baseline assessment.
Time frame
Within 48 hours after stroke.Other outcomes
1
Incidence of symptomatic intracranial hemorrhage.
Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).
Time frame
Within 48 hours after stroke.2
Incidence of any intracranial hemorrhage.
Any intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.
Time frame
Within 48 hours after stroke.3
Incidence of systemic hemorrhage.
The incidence of systemic hemorrhage at any time from randomization through day 90, according to the criteria of the GUSTO.
Time frame
Within 90 days after stroke.4
Incidence of recurrent stroke or other vascular events.
The incidence of recurrent stroke or other vascular events (including hemorrhagic and ischemic stroke, myocardial infarction, and cardiovascular death) within 90 days of randomization.
Time frame
Within 90 days after stroke.Sponsors and contacts
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Source ClinicalTrials.gov