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Effect of DLBS1033 After Primary PCI in Patients With STE-ACS

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ClinicalTrials.gov Identifier: NCT02976701
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Binawaluya Cardiac Hospital, Jakarta
Information provided by (Responsible Party):
Dexa Medica Group

Brief Summary:
This is a prospective, randomized, double-blind, double-dummy, and controlled clinical study over a total of 4-week therapy with DLBS1033 in the management of STE-ACS after a primary PCI. There will be 40 STE-ACS subjects (20 subjects in each group) planned to complete the study.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: DLBS1033 Drug: Placebo Drug: Standard therapy Phase 2 Phase 3

Detailed Description:

STE-ACS patients who undergo intermediate-delayed (> 3 hours after the onset of the STEMI) primary PCI will be enrolled in the study. Before the intervention, they will be given standard medication for PCI.

Right after PCI, all eligible subjects will be assessed for microvascular perfusion, using a pressure-temperature sensor-tipped coronary guidewire.

The day after, in addition to the dual antiplatelet therapy, i.e. 80 mg aspirin once daily and clopidogrel 75 mg once daily, DLBS1033 at a dose of 490 mg three times daily or its placebo will be given to the subjects for 4 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at Baseline (right after subjects undergo the primary PCI) and at the End of study (week 4th of DLBS1033 therapy).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of DLBS1033 in Patients With ST Elevation Acute Coronary Syndrome (STE-ACS) After Primary Percutaneous Coronary Intervention
Study Start Date : November 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: DLBS1033
DLBS1033 enteric-coated tablet is administered at the dose of 490 mg, one tablet three times daily, everyday for four weeks of study period
Drug: DLBS1033
Other Name: Disolf

Drug: Standard therapy
Standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.
Other Name: Asp-Clopi

Placebo Comparator: Placebo
Placebo is administered one tablet three times daily, everyday for four weeks of study period
Drug: Placebo
Drug: Standard therapy
Standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.
Other Name: Asp-Clopi




Primary Outcome Measures :
  1. Index of microvascular resistance (IMR) [ Time Frame: Week 4 ]
    Improvement in the index of microvascular resistance (IMR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.


Secondary Outcome Measures :
  1. Improvement in fractional flow reserve (FFR) from baseline to week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire [ Time Frame: Week 4 ]
    Improvement in fractional flow reserve (FFR) from baseline and to Week 4th of treatment, measured using the pressure and temperature sensor-tipped guidewire.

  2. LV function [ Time Frame: Week 4 ]
    Improvement in several parameters of left ventricular (LV) function [EF, ESV, EDV], from baseline and to Week 4th of treatment will be measured by 2D echocardiography.

  3. Routine hematology [ Time Frame: Week 0 and 4 ]
    Routine hematology, including: RBC, WBC, and platelet count, will be measured at baseline and week 4th of treatment.

  4. Routine hematology (Hemoglobin) [ Time Frame: Week 0, 2 and 4 ]
    Hemoglobin will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.

  5. Routine hematology (Hematocrit) [ Time Frame: Week 0, 2 and 4 ]
    Hematocrit will be measured at baseline and every interval of 2 weeks over the 4 weeks of treatment.

  6. Liver function [ Time Frame: Week 0 and 4 ]
    Liver function measured includes: serum ALT (SGPT), serum AST (SGOT), alkaline phosphatase, and total bilirubin.

  7. Renal function [ Time Frame: Week 0 and 4 ]
    Renal function measured includes: serum creatinine and BUN.

  8. Haemostasis parameter (Prothrombin time (PT)) [ Time Frame: Week 0, 2, and 4 ]
    Prothrombin time (PT) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.

  9. Haemostasis parameter (International Normalized Ratio (INR)) [ Time Frame: Week 0, 2, and 4 ]
    International Normalized Ratio (INR) will be measured at baseline and every interval of 2 weeks over the 4 weeks of study treatment.

  10. Adverse event [ Time Frame: Week 0 - 4 ]
    Adverse events (especially major and minor bleeding) are observed and carefully evaluated along the course of the study.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

KEY Inclusion Criteria:

  1. Signed informed consent.
  2. Men or women of 30-75 years of age.
  3. Evidence of acute ST elevation myocardial infarction (STEMI) at screening, as confirmed by all of the following:

    • Positive plasma cardiac troponin I [cTnI].
    • Possible ischaemic symptoms include various combinations of chest, upper extremity, mandibular or epigastric discomfort (with exertion or at rest) or an ischaemic equivalent such as dyspnoea or fatigue.
    • ECG presentation of STEMI.
  4. The onset of the STEMI is > 3 hours before undergoing the primary PCI.
  5. Therapy with study medication can be started within 24 hours after primary PCI.
  6. Able to take oral medication.

KEY Exclusion Criteria:

  1. Females of childbearing potential: pregnancy, breast-feeding.
  2. History of hemorrhagic stroke, serious head injury within the last 3 months.
  3. History of major surgery within the last 6 months.
  4. History of PCI or CABG, or previous myocardial infarction.
  5. Ongoing long term need for oral anticoagulants, antiplatelets, fibrinolytic, or antithrombotic agents, other than the study medication.
  6. Having any implanted pacemaker or cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy defibrillators (CRT-D).
  7. Present with cardiogenic shock, 3rd degree atrioventricular (AV) block, complex anatomical coronary condition.
  8. Planned for a staged PCI within 30 days after the current PCI
  9. Inadequate liver function
  10. CRUSADE bleeding score of > 30
  11. Known or suspected allergy to other lumbrokinase products.
  12. Prior experience with DLBS1033 or other oral lumbrokinase products.
  13. Clinical evidence of malignancies with survival period < 1 year.
  14. Any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
  15. Subjects enrolled in other interventional protocol within 30 days prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976701


Contacts
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Contact: Muhammad Munawar, SpJP(K), MD +62-21-87781605 muna@cbn.net.id
Contact: Jimmy Agung Pambudi, MD +62-21-87781605 jimmyagung27@gmail.com

Locations
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Indonesia
Binawaluya Cardiac Hospital Recruiting
Jakarta, Indonesia, 13570
Contact: Muhammad Munawar, SpJP(K), MD    +62-21-87781605    muna@cbn.net.id   
Contact: Jimmy Agung Pambudi, MD       jimmyagung27@gmail.com   
Sub-Investigator: Beny Hartono, SpJP, MD         
Sub-Investigator: Jimmy A Pambudi, MD         
Sub-Investigator: Emile TH Parapat, SpJP, MD         
Sponsors and Collaborators
Dexa Medica Group
Binawaluya Cardiac Hospital, Jakarta
Investigators
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Principal Investigator: Muhammad Munawar, SpJP(K), MD Binawaluya Cardiac Hospital

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Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT02976701     History of Changes
Other Study ID Numbers: DLBS1033-0716
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Keywords provided by Dexa Medica Group:
STEMI
acute coronary syndrome
DLBS1033
microvascular resistance index
Left ventricular function

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases