Efficacy of DLBS1033 in Patients With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790997
• Other study ID #: DLBS1033-UST-001.11
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2013
• Last updated: June 3, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• DLBS1033
1 tablet of DLBS1033 490 mg thrice daily, after meal
• Aspirin
1 tablet of aspirin 80 mg once daily, after meal
• Clopidogrel
1 tablet of clopidogrel 75 mg once daily, after meal

Locations

Country	Name	City	State
Indonesia	Stroke Unit, Department of Neurology, Faculty of Medicine, Gadjah Mada University, dr. Sardjito Hospital	Yogyakarta	Jogjakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in INR value	Change in INR (international normalized ratio) value from baseline to end of study (Month 3rd)	3 Months	No
Secondary	Change in PT	Change in PT (prothrombin time) from baseline to end of study (Month 3rd)	3 Months	No
Secondary	Change in aPTT	Change in aPTT (activated-partial thromboplastin time) from baseline to end of study (Month 3rd)	3 Months	No
Secondary	Change in Gadjah Mada Stroke Scale	Change in Gadjah Mada Stroke Scale from baseline to end of study (Month 3rd)	3 Months	No
Secondary	Change in Barthel Index	Change in Barthel Index from baseline to end of study (Month 3rd)	3 Months	No