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Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated June 15, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  2. Secondary endpoints: 9 to 8v5
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2025v4 Show 5 more changesShow less
    • Start date: Nov 1, 2020 to Jan 1, 2021
    • Enrollment target: 290 to 294
    • Study completion date: Jun 30, 2024 to Jun 30, 2026
    • Eligibility criteria revised
    • Collaborators revised (13)
  4. Primary completion date: Dec 30, 2022 to Dec 31, 2023
    • Study completion date: Jun 1, 2023 to Jun 30, 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 9, 2020 to Nov 1, 2020
    • Collaborators expanded, about 60 words
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Previous study showed that the proportions of hemorrhagic Infarction after intravenous thrombolysis were 24.2% and 32.5% in the control group and the alteplase group, and most of them were asymptomatic. Hemorrhagic Infarction was a part of the natural progression after acute ischemic stroke. Previous study have shown no significant relationship between hemorrhagic Infarction and poor outcome in acute ischemic stroke (AIS) patients. In this study, a randomized controlled trial will be conducted to explore the efficacy and safety of early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis.
Trial Details
NCT Number NCT04624295
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators: Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, The Second Affiliated Hospital of Jiaxing University, Jinhua Central Hospital, Taizhou Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo No.2 Hospital, Lishui Country People's Hospital, Wenzhou Central Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Shenzhen Second People's Hospital, The Affiliated Hospital of Xuzhou Medical University
Conditions
(from sponsor)		 Antiplatelet Therapy, Hemorrhagic Infarction
Related terms Ischemic Stroke
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov