Overview

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