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

SK chemicals

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke

Treatments: Drug: Plavix 75mg; Drug: Renexin CR 200/160mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05445895

RNX_002

Details and patient eligibility

About

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

Enrollment: 483 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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483 participants in 2 patient groups

Renexin CR 200/160mg

Experimental group

Description:

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

Treatment:

Drug: Renexin CR 200/160mg

Clopidogrel 75mg

Active Comparator group

Description:

Plavix 75mg will be added to Aspirin 100mg

Treatment:

Drug: Plavix 75mg