Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Dexa Medica

Status and phase: Completed; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Drug: DLBS1033; Drug: Clopidogrel; Drug: Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01790997

DLBS1033-UST-001.11

Details and patient eligibility

About

This is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of DLBS1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

Full description

There will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens :

Treatment I : 1 tablet of DLBS1033 490 mg thrice daily, after meal Treatment II : 1 tablet of aspirin 80 mg once daily, after meal Treatment III : 1 tablet of clopidogrel 75 mg once daily, after meal

Bleeding profile (by measuring INR value, PT, and aPTT) and clinical outcome (by measuring Gadjah Mada Stroke Scale and Barthel Index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (Month 3rd). General condition of the subjects will be followed-up every month over three months of study medication.

Physiotherapy will be provided to the subjects by the assigned Physiotherapist.

Enrollment: 126 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 20-80 years old
• Having non-bleeding stroke in CT scan examination
• Having stroke attack onset ≤ 96 hours
• Living in 100 km from RSUP Dr Sardjito Jogjakarta

Exclusion criteria

• Having recurrence stroke
• Having Transient Ischemic Attack (TIA)
• Have been regularly taking anti-aggregation agent
• Having intracerebral and subarachnoid bleeding stroke
• Subjects and their family do not know when the stroke symptoms appeared
• History of haemostasis disorder
• History of or will have surgery within 6 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 3 patient groups

Treatment I

Experimental group

Description:

1 tablet of DLBS1033 490 mg thrice daily, after meal

Treatment:

Drug: DLBS1033

Treatment II

Active Comparator group

Description:

1 tablet of aspirin 80 mg once daily, after meal

Treatment:

Drug: Aspirin

Treatment III

Active Comparator group

Description:

1 tablet of clopidogrel 75 mg once daily, after meal

Treatment:

Drug: Clopidogrel