A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

483 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2025-11-07

Brief Summary

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A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke

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Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Renexin CR 200/160mg

Renexin CR 200/160mg will be added to Aspirin 100mg

Group Type EXPERIMENTAL

Renexin CR 200/160mg

Intervention Type DRUG

Renexin CR 200/160mg will be added to Aspirin 100mg

Clopidogrel 75mg

Plavix 75mg will be added to Aspirin 100mg

Group Type ACTIVE_COMPARATOR

Plavix 75mg

Intervention Type DRUG

Plavix 75mg will be added to Aspirin 100mg

Interventions

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Renexin CR 200/160mg

Renexin CR 200/160mg will be added to Aspirin 100mg

Intervention Type DRUG

Plavix 75mg

Plavix 75mg will be added to Aspirin 100mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.

Exclusion Criteria

1. Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
2. With a modified Rankin Score (mRS) of 3 or higher before onset.
3. Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
4. History of hypersensitivity to IP or components
5. Not suitable for aspirin administration at the discretion of the investigator

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No