Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

• ClinicalTrials.gov Identifier: NCT02982590
• Recruitment Status: Completed
• First Posted: December 5, 2016
• Results First Posted: July 8, 2021
• Last Update Posted: July 8, 2021
• Sponsor: Universiti Sains Malaysia
• Collaborator: Institut Jantung Negara
• Information provided by (Responsible Party): Dr W. Yus Haniff W. Isa, Universiti Sains Malaysia

Study Description

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 3 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 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
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: November 2018
• Actual Study Completion Date: November 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percent Change in Left Ventricular Thrombus (LVT) Size [ Time Frame: 3 months ]
   Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment

Secondary Outcome Measures :

1. Change of Left Ventricular Thrombosis (LVT) by More Than 50% [ Time Frame: 3 months ]
   Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.
2. Clinically Definite Cardiac Embolic Ischemic Stroke [ Time Frame: 3 months ]
   Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan
3. Life Threatening Bleeding [ Time Frame: 3 months ]
   Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Malaysia

Hospital Universiti Sains Malaysia

Kota Bharu, Kelanatan, Malaysia, 16150

Sponsors and Collaborators

Universiti Sains Malaysia

Institut Jantung Negara

Investigators

• Principal Investigator: Dr W. Yus Haniff W. Isa, M.MED; Universiti Sains Malaysia

  Study Documents (Full-Text)

Documents provided by Dr W. Yus Haniff W. Isa, Universiti Sains Malaysia:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] December 12, 2015

More Information

• Responsible Party: Dr W. Yus Haniff W. Isa, DR, Universiti Sains Malaysia
• ClinicalTrials.gov Identifier: NCT02982590
• Other Study ID Numbers: 304/PPSP/61313197
• First Posted: December 5, 2016
• Results First Posted: July 8, 2021
• Last Update Posted: July 8, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Warfarin; Apixaban; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action