Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

NCT01790997 | Completed Phase 3

• 1 other identifier: DLBS1033-UST-001.11
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

DLBS1033; Lumbrokinase; Acute ischemic stroke; Bleeding profile; Clinical outcome; Aspirin; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• Change in INR value

  Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)

  3 Months

Secondary Outcomes (4)

• Change in PT

  3 Months

• Change in aPTT

  3 Months

• Change in Gadjah Mada Stroke Scale

  3 Months

• Change in Barthel Index

  3 Months

Study Arms (3)

Treatment I

EXPERIMENTAL

1 tablet of DLBS1033 490 mg thrice daily, after meal

Drug: DLBS1033

Treatment II

ACTIVE COMPARATOR

1 tablet of aspirin 80 mg once daily, after meal

Drug: Aspirin

Treatment III

ACTIVE COMPARATOR

1 tablet of clopidogrel 75 mg once daily, after meal

Drug: Clopidogrel

Interventions

DLBS1033 DRUG

1 tablet of DLBS1033 490 mg thrice daily, after meal

Treatment I

Aspirin DRUG

1 tablet of aspirin 80 mg once daily, after meal

Treatment II

Clopidogrel DRUG

1 tablet of clopidogrel 75 mg once daily, after meal

Treatment III

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (1)

Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital

Yogyakarta, Jogjakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

DLBS 1033; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ismail Setyopranoto, dr., SpS(K)

  Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 13, 2013
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 4, 2014

Record last verified: 2014-01

Locations

ID (1)