Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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