NCT07456085

Brief Summary

Warfarin is the standard anticoagulant used for patients with mechanical heart valves; however, its use is complicated by a narrow therapeutic window, frequent drug and dietary interactions, and the need for regular international normalized ratio (INR) monitoring. In resource-limited settings such as Pakistan, many patients have difficulty accessing reliable INR testing, which can result in suboptimal anticoagulation and increased risks of thromboembolic or bleeding complications. Rivaroxaban, a direct oral factor Xa inhibitor, offers predictable pharmacokinetics and does not require routine laboratory monitoring, making it a potentially more convenient option for patients with limited access to INR testing. This prospective comparative study aims to evaluate rivaroxaban as an alternative to warfarin in patients with mechanical heart valves. Sixty adult patients will be enrolled and followed for one year, comparing the incidence of thromboembolic and bleeding events between patients treated with rivaroxaban and those maintained on dose-adjusted warfarin.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
10mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Nov 2025Apr 2027

Study Start

First participant enrolled

November 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

January 20, 2026

Last Update Submit

March 12, 2026

Conditions

Valvular Heart Disease Patients

Keywords

mechanical heart valveDirect Oral Anticoagulant (DOAC)ThromboembolismBleedingcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of Thromboembolic Events

    Description: Incidence of participants experiencing at least one thromboembolic event (stroke, TIA, prosthetic valve thrombosis, DVT, or PE) during follow-up. Unit of Measure: Number of participants with ≥1 event; proportion (%)

    12 months from treatment initiation

Secondary Outcomes (4)

  • Incidence of Major Bleeding

    12 months

  • Incidence of Clinically Relevant Non-Major Bleeding (if applicable)

    12 months

  • All-Cause Mortality

    12 months

  • Anticoagulation-Related Hospital Visits

    12 months

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

Rivaroxaban Group: Patients will be started on Rivaroxaban 20 mg once daily, as per the standard dose for mechanical heart valves along with Aspirin 75mg once daily Doze will be titrated according to weight.those with weight greater than 80 kg will be given tab rivoroxaban 15 mg BD alongwith asprin 75 mg OD .

Drug: Rivoroxaban

warfarin

ACTIVE COMPARATOR

second arm will be given conventional warfarin conventional

Drug: Warfarin

Interventions

RivoroxabanDRUG

Intervention Arm: Rivaroxaban Participants will receive rivaroxaban as an alternative anticoagulant to warfarin for mechanical heart valves. Rivaroxaban will be administered at 20 mg once daily (or 15 mg twice daily for patients \>80 kg), along with aspirin 75 mg once daily unless contraindicated. Initial factor Xa levels will be used to guide dose adjustment, followed by routine clinical evaluation and echocardiographic monitoring. This intervention aims to assess whether rivaroxaban can safely and effectively provide therapeutic anticoagulation in patients who have warfarin-related complications or poor access to INR monitoring.

Rivaroxaban
WarfarinDRUG

Patients will be treated with conventional tablet warfarin as per standard protocol and will maintain INR as per AHA guidelines

warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years) with mechanical heart valves
  • History of thromboembolic or bleeding complications while on warfarin or limited access to INR testing
  • Ability and willingness to provide informed consent

You may not qualify if:

  • Contraindication to rivaroxaban
  • Hemorrhagic stroke or ischemic stroke within the past 3 months
  • Severe renal impairment (creatinine clearance \<30 mL/min)
  • Increased risk of bleeding due to congenital or acquired disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (3)

  • Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap ÁF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28. PMID: 27030066.

    BACKGROUND

  • Duraes AR, de Souza Lima Bitar Y, Schonhofen IS, Travassos KSO, Pereira LV, Filho JAL, Neto MG, Junior RA, Roever L. Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial-The RIWA study. Am J Cardiovasc Drugs. 2021 May;21(3):363-371. doi: 10.1007/s40256-020-00449-3. Epub 2020 Nov 5. PMID: 33150497.

    BACKGROUND

  • Roost E, Weber A, Alberio L, Englberger L, Reineke D, Keller D, Nagler M, Carrel T. Rivaroxaban in patients with mechanical heart valves: A pilot study. Thromb Res. 2020 Feb;186:1-6. doi: 10.1016/j.thromres.2019.12.005. Epub 2019 Dec 7. PMID: 31837559.

    BACKGROUND

Related Links

MeSH Terms

Conditions

ThromboembolismHemorrhage

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional (Clinical Trial) - This study involves prospective assignment of participants to different interventions (rivaroxaban vs. warfarin) to evaluate their effects on thromboembolic and bleeding outcomes in patients with mechanical heart valves. Allocation: Non-randomized (Parallel Assignment) * Participants will be assigned to one of two groups based on predefined clinical criteria (e.g., warfarin complications, poor INR accessibility). * Both groups will be followed concurrently.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director Rawalpindi Institute of Cardiology

Study Record Dates

First Submitted

January 20, 2026

First Posted

March 6, 2026

Study Start

November 13, 2025

Primary Completion (Estimated)

April 12, 2027

Study Completion (Estimated)

April 12, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)