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Submitted by: Antonio Miguel L. Dans 2019-09-02 11:52:39 Last Updated by: Principe, Jeverly Ann S 2019-09-04 09:42:22


INVestIgation of rheumatiC AF Treatment Using vitamin K antagonists, rivaroxaban or aspirin Studies (INVICTUS)

PHRR190904-002189

Version 3.0-2015-10-19

2016-CT0335

INVestIgation of rheumatiC AF Treatment Using vitamin K antagonists, rivaroxaban or aspirin Studies (INVICTUS)

This program is a comprehensive evaluation of RVHD, AF/Flutter and stroke. It includes three major components

1. A multi-centre registry of RVHD

2. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard VKA therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.

3. A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF with high risk factors.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-02-02 48 2021-02-02 2023-12-31

Ongoing

Institution Classification Region LTO #
Population Health Research Institute Private Business Canada LTO-3000003135427
Institution Region
Population Health Research Institute Canada
Name E-Mail Institution and Institution Address
Antonio L. Dans, MD antoniodans@gmail.com Section of Adult Medicine ground floor back of Ward 3, Philippine General Hospital, Taft Avenue, Ermita, Manila
Name E-Mail Institution and Institution Address
Antonio L. Dans, MD antoniodans@gmail.com Section of Adult Medicine ground floor back of Ward 3, Philippine General Hospital, Taft Avenue, Ermita, Manila
Name Expertise Affiliation
Dennis Sulit, MD Principal Investigator Quirino Memorial Medical Center
Maria Teresa B. Abola, MD Principal Investigator Philippine Heart Center
Project Location Institutional Ethics Review Board
Quirino Memorial Medical Center Quirino Memorial Medical Center Hospital Ethics Committee
Philippine Heart Center Philippine Heart Center Ethics Review Committee

 Rheumatic Valvular Heart Disease, Atrial Fibrillation/Flutter

 -All stroke by sub-type

-Systemic embolism

-Myocardial infarction

-Death by cause

-Recurrent rheumatic fever

-Prosthetic valve thrombosis

-Ineffective endocarditis

-Hospitalization for any cause

-Valvuloplasty/Surgery

-Infections-Pneumonia, HIV etc

 Total Death

Vascular Death

 

Recruiting

  • Philippines

Clinical Trial

Version 3.0-2015-10-19

20160104084229

2017-01-30

0000-00-00

400

92

focused on recruiting in RCT patients

02 Feb 2017

 1. Refusal to consent

2. Actively involved in any study that would compromise the protocol of INVICTUS trial

3. Severe co-morbid condition with life expectancy < 1 year'

4. Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region

5. Likely to have valve replacement surgery within 6 months

6. Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.

7. Contraindication to the study medication of the trial

a. Allergy to rivaroxaban

b. Allergy t o VKAs (non-inferiority)

c. Allergy to aspirin (superiority)

8. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15ml/min

9. Serious bleeding in the past six months or at high risk of bleeding

10. Moderate to severe hepatic impairment

11. Ongoing need for dual anti platelet therapy (patients with ongoing aspirin therapy < 100mg per day are not excluded)

12. Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.

13. Received an investigational drug in the past 30 days.

14. Patients considered unsuitable for trial inclusion because of unwillingness to attent follow-up visits.

15. Women who are pregnant and/or breastfeeding.

16. Women of child bearing age who do not use an effective form of birth control.

Observational

Unspecified

Unspecified

Date Amendment Classification Reason
2017-09-23 Amendments related to the protocol Purpose of trial

Randomized

Open Label

Unspecified

Parallel

 The overarching goals of the registry are to document variations in disease characteristics and treatment patterns across countries and document the rates of important clinical outcomes in patients with RVHD. In addition, this large registry will be designed to serve as a platform for registry-based randomized controlled trials (RCT) testing the efficacy of novel interventions (including the use of rivaroxaban for patients at high risk of stroke)

Phase I/II

Utilization Utilization Info
Publication

 N/A

Oral Presentation

 N/A

Drug Literature

 N/A

Posters

 N/A

Others

 N/A

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