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Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Study acronym: TREND-IVT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Mar 2026 → Dec 2027
See other at-risk trials from Capital Medical University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Mar 2026 to Dec 2027 Show 4 more changesShow less
    • Trial sites expanded: 71 → 119 locations
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Publications: details revised at 6 of 6 entries
  2. Minor Study sites: 23 to 71
    • Eligibility criteria expanded, about 26 words
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2024 to Nov 7, 2024
    • Site details revised at 23 of 23 sites
    v3
  4. Notable Start date: Aug 2024 to Nov 2024v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06548971
Lead Sponsor Capital Medical University
Conditions
(from sponsor)
Acute Ischemic Stroke, Cerebral Infarction
Related terms Cerebral Infarction, Ischemic Stroke
Enrollment 1,184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov