Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: DLBS1033; Drug: Aspirin; Drug: Clopidogrel

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jogjakarta
    • Yogyakarta, Jogjakarta, Indonesia, 55281
      • Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment I; 1 tablet of DLBS1033 490 mg thrice daily, after meal	Drug: DLBS1033; 1 tablet of DLBS1033 490 mg thrice daily, after meal
ACTIVE_COMPARATOR: Treatment II; 1 tablet of aspirin 80 mg once daily, after meal	Drug: Aspirin; 1 tablet of aspirin 80 mg once daily, after meal
ACTIVE_COMPARATOR: Treatment III; 1 tablet of clopidogrel 75 mg once daily, after meal	Drug: Clopidogrel; 1 tablet of clopidogrel 75 mg once daily, after meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in INR value	Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PT	Change in PT (prothrombin time) from baseline to end of study (Month 3rd)	3 Months
Change in aPTT	Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)	3 Months
Change in Gadjah Mada Stroke Scale	Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)	3 Months
Change in Barthel Index	Change in Barthel Index from baseline to end of study (Month 3rd)	3 Months

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Ismail Setyopranoto, dr., SpS(K), Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Aspirin; Clopidogrel; Acute ischemic stroke; Clinical outcome; DLBS1033; Lumbrokinase; Bleeding profile
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: DLBS1033-UST-001.11