Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

NCT ID: NCT02982590

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

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.

Conditions

Left Ventricular Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

warfarin sodium

warfarin daily, dosage according to INR monitor. Aim INR 2-3

Group Type: ACTIVE_COMPARATOR

Warfarin Sodium

Intervention Type: DRUG

as controlled arm since warfarin is the standard therapy for LV thrombus

apixaban

Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months.

Group Type: EXPERIMENTAL

Apixaban 5 MG Oral Tablet [ELIQUIS]

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Warfarin Sodium

as controlled arm since warfarin is the standard therapy for LV thrombus

Intervention Type: DRUG

Other Intervention Names

ELIQUIS; Coumadin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Jantung Negara

OTHER

Sponsor Role: collaborator

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Dr W. Yus Haniff W. Isa

DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr W. Yus Haniff W. Isa, M.MED

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Hospital Universiti Sains Malaysia

Kota Bharu, Kelanatan, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

304/PPSP/61313197

Identifier Type: -

Identifier Source: org_study_id