Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01790997
First received: February 12, 2013
Last updated: June 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Drug: DLBS1033
Drug: Aspirin
Drug: Clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Change in INR value [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)


Secondary Outcome Measures:
  • Change in PT [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in PT (prothrombin time) from baseline to end of study (Month 3rd)

  • Change in aPTT [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)

  • Change in Gadjah Mada Stroke Scale [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)

  • Change in Barthel Index [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in Barthel Index from baseline to end of study (Month 3rd)


Enrollment: 126
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790997

Locations
Indonesia
Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital
Yogyakarta, Jogjakarta, Indonesia, 55281
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01790997     History of Changes
Other Study ID Numbers: DLBS1033-UST-001.11
Study First Received: February 12, 2013
Last Updated: June 3, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
DLBS1033
Lumbrokinase
Acute ischemic stroke
Bleeding profile
Clinical outcome
Aspirin
Clopidogrel

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on July 28, 2014