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Trial record 41 of 734 for:    warfarin

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

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ClinicalTrials.gov Identifier: NCT02982590
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
INSTITUT JANTUNG NEGARA
Information provided by (Responsible Party):
Dr W. Yus Haniff W. Isa, University of Science Malaysia

Brief Summary:
The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 6 months.

Condition or disease Intervention/treatment Phase
Left Ventricular Thrombosis Drug: Apixaban 5 MG Oral Tablet [ELIQUIS] Drug: Warfarin Sodium Phase 3

Detailed Description:

Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).

Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: warfarin sodium
warfarin daily, dosage according to INR monitor. Aim INR 2-3
Drug: Warfarin Sodium
as controlled arm since warfarin is the standard therapy for LV thrombus
Other Name: Coumadin

Experimental: apixaban
Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.
Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]
Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
Other Name: ELIQUIS




Primary Outcome Measures :
  1. Reduction of left ventricular thrombus size in cm2 (0 = total resolution) [ Time Frame: 3 months ]
    Reduction of left ventricular thrombus size in cm2 (0 = total resolution)


Secondary Outcome Measures :
  1. Reduction of left ventricular thrombosis by more than 50% [ Time Frame: 3 months ]
  2. Evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan [ Time Frame: 3 months ]
  3. Life threatening bleeding attributed to the use of anti-coagulation [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 80 years old
  2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
  3. HASBLED score less than 3
  4. No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

Exclusion Criteria:

  1. Patient with unstable arrhythmias and/or recurrent cardiogenic shock
  2. Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
  3. Patient with permanent pacemaker
  4. Patient who is post valve replacement therapy
  5. Patient who is pregnant.
  6. Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)
  7. Patient with advanced liver disease with coagulopathy
  8. Patient with organized and old left ventricular thrombus

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): NCT02982590


Contacts
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Contact: Dr W. Yus Haniff W. Isa, M.MED +60199228373 wyhaniff@usm.my
Contact: Dr Niny Hwong, MD +60128592892 ninyhw@gmail.com

Locations
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Malaysia
Hospital Universiti Sains Malaysia Recruiting
Kota Bharu, Kelanatan, Malaysia, 16150
Contact: Dr W. Yus Haniff W. Isa    60199228373      
Sponsors and Collaborators
University of Science Malaysia
INSTITUT JANTUNG NEGARA

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Responsible Party: Dr W. Yus Haniff W. Isa, DR, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT02982590     History of Changes
Other Study ID Numbers: 304/PPSP/61313197
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Warfarin
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action