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Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT01790997
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group

Tracking Information
First Submitted Date  ICMJE February 12, 2013
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
Change in INR value [ Time Frame: 3 Months ]
Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01790997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2013)
  • Change in PT [ Time Frame: 3 Months ]
    Change in PT (prothrombin time) from baseline to end of study (Month 3rd)
  • Change in aPTT [ Time Frame: 3 Months ]
    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 ]
    Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)
  • Change in Barthel Index [ Time Frame: 3 Months ]
    Change in Barthel Index from baseline to end of study (Month 3rd)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke
Official Title  ICMJE The Role of DLBS1033 in Evaluating Bleeding Profile and Clinical Outcome in Patients With Acute Ischemic Stroke: Comparison With Aspirin and Clopidogrel
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Drug: DLBS1033
    1 tablet of DLBS1033 490 mg thrice daily, after meal
  • Drug: Aspirin
    1 tablet of aspirin 80 mg once daily, after meal
  • Drug: Clopidogrel
    1 tablet of clopidogrel 75 mg once daily, after meal
Study Arms  ICMJE
  • Experimental: Treatment I
    1 tablet of DLBS1033 490 mg thrice daily, after meal
    Intervention: Drug: DLBS1033
  • Active Comparator: Treatment II
    1 tablet of aspirin 80 mg once daily, after meal
    Intervention: Drug: Aspirin
  • Active Comparator: Treatment III
    1 tablet of clopidogrel 75 mg once daily, after meal
    Intervention: Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2014)
126
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2013)
129
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01790997
Other Study ID Numbers  ICMJE DLBS1033-UST-001.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dexa Medica Group
Study Sponsor  ICMJE Dexa Medica Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ismail Setyopranoto, dr., SpS(K) Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital, Jogjakarta, Indonesia
PRS Account Dexa Medica Group
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP