NCT05193071

Brief Summary

The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,022

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

December 31, 2021

Last Update Submit

October 29, 2024

Conditions

Ischemic Stroke

Keywords

thrombolysisminor strokeearly antiplatelet

Outcome Measures

Primary Outcomes (1)

  • The proportion of excellent prognosis

    excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    Day 90

Secondary Outcomes (8)

  • The proportion of favorable prognosis

    Day 90

  • Distribution of modified Rankin Score (mRS)

    Day 90

  • Changes in National Institute of Health stroke scale (NIHSS)

    24 hours, 48 hours, and 10 days

  • Occurrence of early neurologyical deterioration (END)

    24 hours

  • The incidence of symptomatic intracerebral hemorrhage

    36 hours

  • +3 more secondary outcomes

Study Arms (2)

double antiplatelet group

EXPERIMENTAL

aspirin 100mg plus clopidogrel 300mg

Drug: Aspirin 100mg; Clopidogrel 300mg

control group

PLACEBO COMPARATOR

aspirin placebo plus clopidogrel placebo

Drug: Aspirin 100mg; Clopidogrel 300mg

Interventions

Aspirin 100mg; Clopidogrel 300mgDRUG

Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

control groupdouble antiplatelet group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old;
  • Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
  • NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
  • Premorbid mRS ≤ 1;
  • Signed informed consent.

You may not qualify if:

  • Premorbid mRS≥2;
  • Uncontrolled severe hypertension (systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg after drug treatment);
  • Antithrombotic treatment within 24 hours before randomization;
  • Significant dysphagia and inability to take the experimental drug orally;
  • Allergy or contraindication to study drugs;
  • Comorbidity with any serious diseases and life expectancy is less than half a year;
  • Participating in other clinical trials within three months;
  • Patients not suitable for this clinical study considered by researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hui-sheng Chen

Shenyang, None Selected, 110840, China

Location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

July 8, 2022

Primary Completion

October 25, 2024

Study Completion

October 25, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

CN(2)