Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- Clinical Trial

NCT05973188 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: IRC/23/09
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to design this randomized control trial to compare rivaroxaban and apixaban with warfarin in Left ventricular thrombus resolution by

• Success rate of left ventricular thrombus resolution on follow up echocardiograms to be done at 1st, 3rd and 6th months after starting on these drugs.
• Compare the adverse events of each drug in terms of major bleeding and stroke on follow up. Left ventricular thrombus (LVT) leads to thromboembolism in about 10-15% cases. Currently, guidelines recommended therapy for LVT is warfarin but treating LVT with warfarin is challenging due to
• Its narrow therapeutic window.
• Drug-drug and drug-food interaction.
• Frequently tested International normalization ratio (INR) and cost effectiveness especially in low to middle income countries. In contrast Rivaroxaban and Apixaban has no drug-food or major drug-drug interaction and moreover it doesn't require frequent checks on INR and that's the reason Rivaroxaban and apixaban use in LVT is gaining traction over time but there is paucity of data both nationally and internationally. So further studies are required to evaluate the efficacy and safety of rivaroxaban and apixaban in comparison to warfarin in LVT, especially in low to middle income countries.

Conditions

Left Ventricular Thrombus

Keywords

Left ventricular thrombus, warfarin, rivaroxaban, apixaban

Outcome Measures

Primary Outcomes (1)

• Successful resolution of LV thrombus by Rivaroxaban and Apixaban in comparison to Warfarin

  Presence or absence of LV thrombus at one, three and six months follow up on echocardiogram.

  Within 6months of randamization

Secondary Outcomes (3)

• Time from start of drug to thrombus resolution in months

  Within 6 months of randomization

• No of events of major bleeding (defined by International Society of Thrombosis and Hemostasis criteria)

  Within 6 months of randomization

• No of events of stroke (both ischemic and hemorrhagic)

  Within 6 months of randomization

Study Arms (3)

Group A, warfarin group

ACTIVE COMPARATOR

Patients started on warfarin, dose will be adjusted according to patient target INR (2-3)

Drug: Warfarin

Group B, Rivaroxaban (Xcept)

EXPERIMENTAL

Patients started on rivaroxaban 20mg single dose in 24hours

Drug: Rivaroxaban 20 MG Oral Tablet

Group C, Apixaban ( Apixaget)

EXPERIMENTAL

Patients started on Apixaban 5mg or 2.5mg (12hours apart)

Drug: Apixaban 5mg or 2.5mg oral tablet

Interventions

Warfarin DRUG

Anticoagulant

Also known as: Warfarin oral tablet

Group A, warfarin group

Rivaroxaban 20 MG Oral Tablet DRUG

Anticoagulant

Also known as: Xcept

Group B, Rivaroxaban (Xcept)

Apixaban 5mg or 2.5mg oral tablet DRUG

Anticoagulant

Also known as: Apixaget

Group C, Apixaban ( Apixaget)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All hemodynamically stable patients with LV thrombus on echocardiogram after.

You may not qualify if:

• Chronic Liver Disease (CLD) patients
• Creatinine clearance less than 15ml/min
• Recent Hemorrhagic stroke
• Thrombocytopenia, platelets \<50k or anemia with baseline HB \<9mg/dl
• Recent Major GI bleed
• History of atrial fibrillation and mitral stenosis
• History of deep vein thrombosis/pulmonary embolism and Patients already on anticoagulation

Sponsors & Collaborators

• Peshawar Institute of Cardiology: lead
• Getz Pharma: collaborator

Study Sites (1)

Peshawar Institute of Cardiology

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Interventions

Warfarin; Rivaroxaban; apixaban; Tablets

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ihsan Ullah, MD

  Peshawar Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ihsan Ullah, MD

CONTACT

+923365948083; dr.ihsanulla@gmail.com

Ali Raza, MRCP

CONTACT

+923430978366

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomized and open label. We will randomly assign first patient into group A that is control group (warfarin group) then next patient to group B (rivaroxaban group) and then next patient into group C (Apixaban group). We will repeat the cycle to achieve the target sample size in each group. Patients will be randomized in group A, B and C in a ratio of 1:1:1, to either control group A (Warfarin group with dose adjusted, target INR 2-3), group B (Rivaroxaban 20mg QD) and group C (Apixaban 5mg BD or 2.5mg BD if having two or more of the following, patients with age ≥80years and/or creatinin≥1.5 and/or body weight ≤60kg). LVT resolution will be assessed by blinded cardiologist via transthoracic echocardiogram at 1, 3 and 6 months' interval after starting on the respective regimen.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: August 2, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

PA (1)