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

NCT05973188 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2023-08-02

No results posted yet for this study

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

Interventions

DRUG

Warfarin

Anticoagulant

DRUG

Rivaroxaban 20 MG Oral Tablet

Anticoagulant

DRUG

Apixaban 5mg or 2.5mg oral tablet

Anticoagulant

Sponsors & Collaborators

  • Getz Pharma

    collaborator INDUSTRY

  • Peshawar Institute of Cardiology

    lead OTHER_GOV

Principal Investigators

  • Ihsan Ullah, MD · Peshawar Institute of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05973188 on ClinicalTrials.gov