NCT04624295

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Jan 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jan 2021Jun 2026

First Submitted

Initial submission to the registry

October 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 15, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

October 29, 2020

Last Update Submit

June 11, 2025

Conditions

Antiplatelet TherapyHemorrhagic Infarction

Keywords

acute ischemic strokeintravenous thrombolysisHemorrhagic Infarctionantiplatelet therapy

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with modified Rankin scale (mRS) ≤2

    The proportion of patients with modified Rankin scale (mRS) ≤2 at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)\].

    90 days

Secondary Outcomes (8)

  • Hemorrhage enlargement after intravenous thrombolysis

    7 days

  • Hemorrhage reduction after intravenous thrombolysis

    7 days

  • the progress of National Institute of Health Stroke Scale (NIHSS) scores

    7 days

  • the distribution of modified Rankin scale (mRS)

    90 days

  • Recurrence rate of acute ischemic stroke

    90 days

  • +3 more secondary outcomes

Study Arms (2)

Early Antiplatelet Therapy

ACTIVE COMPARATOR
Drug: Early aspirin Therapy

Non-Early Antiplatelet Therapy

PLACEBO COMPARATOR
Drug: Non-Early aspirin Therapy

Interventions

Early aspirin TherapyDRUG

Early Antiplatelet Therapy is administered within 24 to 48 hours after stroke onset and the dose is determined by the clinician. Aspirin was chosen for antiplatelet therapy.

Early Antiplatelet Therapy
Non-Early aspirin TherapyDRUG

Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.

Non-Early Antiplatelet Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic patients receiving intravenous thrombolysis within 24 hours upon stroke onset
  • Be confirmed as Hemorrhagic Infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography
  • The patient or family member signed an informed consent

You may not qualify if:

  • Early use of anticoagulant drugs within 1 week after intravenous thrombolysis;
  • Tirofiban was used after receiving endovascular treatment;
  • Intraoperative stent placement after receiving endovascular treatment;
  • Subarachnoid hemorrhage or ventricular hemorrhage;
  • There are contraindications for aspirin use;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Min Lou, PhD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Min Lou, PhD

CONTACT

+8657187784810loumingxc@vip.sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 10, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)