search
Back to results

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority (INVICTUS-VKA)

Primary Purpose

Rheumatic Heart Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban (20 mg)
Vitamin K antagonists (VKA)
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatic Heart Disease focused on measuring atrial fibrillation, stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. RVHD diagnosed by echocardiography at any time prior to enrollment
  2. Age ≥18

  3. Increased risk of stroke by any of the following

    • CHA2DS2-VASc score ≥ 2 OR
    • Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
    • Left atrial spontaneous echo contrast OR
    • Left atrial thrombus
  4. Heart Rhythm *AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram.

Exclusion Criteria:

  1. Refusal to give informed 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

    • Allergy to rivaroxaban
    • Allergy to VKAs ( non-inferiority trial)
    • Allergy to aspirin ( superiority trial)
  8. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15 ml/min
  9. Serious bleeding in the past six months or at high risk for bleeding
  10. Moderate to severe hepatic impairment
  11. Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg 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 attend 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.

Sites / Locations

  • Princess Marina Hospital
  • Cardresearch - Cardiologia Assistencial e de Pesquisa
  • Nucleo de Estudios Clinicos - Universidade Federal do Triângulo Mineiro
  • Eurolatino Pesquisas Médicas Ltda
  • Clínica Procardio Ltda.
  • Instituto de Pesquisa Clínica de Campinas
  • LOEMA - Instituto de Pesquisa Clínica & Consultores Ltda
  • Via Médica Centro Clínico Barroso e Sebba Ltda
  • Instituto de Cardiologia do Rio Grande do Sul
  • Fundação Faculdade de Medicina de São José do Rio Preto
  • Instituto do Coração - HCFMUSP
  • Instituto Dante Pazzanese de Cardiologia
  • Santa Casa de Misericórdia de Votuporanga
  • Clinique Coeur Et Vie
  • Douala General Hospital
  • St. Elizabeth Catholic General Hospital, Cardiac Centre
  • Hopital Central Yaounde
  • Liangxiang Hospital
  • The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
  • Jixi People's Hospital
  • Tieli People's Hospital
  • Luoyang Central's Hospital Affiliated to Zhengzhou University
  • Dancheng County People's Hospital
  • Suiping Renan Hospital
  • Jianshi County People's Hospital
  • Suqian Peaple's Hospital of Nanjing Drum-Tower Hospital Group
  • Tonghua Central Hospital
  • Affiliated Zhongshan Hospital of Dalian University
  • The First Affiliated Hospital of Dalian Medical University
  • Ningxia Peple's Hospital
  • Pi County People's Hospital
  • Anyue County People's Hospital
  • Wendeng Central Hospital
  • Ninghai People's Hospital
  • Beijing Anzhen Hospital
  • Zhongmou County People's Hospital
  • Zhengzhou No.7 People's Hospital
  • Zhengzhou 9th People's Hospital
  • Guangshan County People's Hospital
  • Alexandria University Hospital
  • Assuit General Hospital
  • Benha University Cardiology Department
  • Beni Suef University Hospital
  • Ain Shams University Hospital
  • Kasr El Einy Hospital (Cairo University)
  • Mehallah Rheumatic Heart Center
  • Specialized Medical Hospital - Mansoura
  • Fayoum General Hospital
  • Suez Canal University Hospital
  • El Minia University Hospital
  • Sohag University, Sohag
  • Red Crescent Hospital
  • Zagazig University Hospital
  • Hawassa University Referral Hospital
  • College of Health Sciences, Addis Ababa University, Black Lion Hospital
  • Jimma University Hospital
  • Mekelle University
  • Dr. Ram Manohar Lohia Hospital @ PGIMER
  • Govind Ballabh Pant Hospital (GIPMER)
  • All India Institute of Medical Sciences
  • Sri Jayadev Institute of Cardiovascular Sciences and Research
  • SMS Medical College
  • King George's Medical College
  • Sanjay Gandhi Post Graduate Institute of Medical Sciences
  • Kazakh National Medical Institute,
  • Moi Teaching and Referral Hospital
  • Karen Hospital
  • Kenyatta National Hospital / University Of Nairobi
  • Clinical Hospital of administrative department of President and Government of Kyrgyz Republic
  • Queen Elizabeth Central Hospital
  • Kumuzu Central Hospital
  • Mzuzu Central Hospital
  • Hospital Angeles León
  • Hospital Bernardette
  • Centro de Estudios Clínicos de Querétaro S.C.
  • Centro para el Desarrollo de la Medicina y Asistencia Especializada S.C.
  • Instituto de Investigación del Hospital Cardiológica Aguascalientes
  • Hospital General Dr. Jorge Soberon Acevedo.Secretaria de Salud del Estado de Guerrero
  • Instituto Nacional de Cardiología Ignacio Chavez
  • Maputo Central Hospital
  • Instituto Nacional de Saude & Universidade Eduardo Mondlane
  • College of Medical Sciences
  • Chitwan Medical College
  • Nobel medical college and teaching hospital pvt ltd
  • Gautam Buddha Community Heart Hospital
  • BP Koirala Institute of Health Sciences
  • Manmohan Cardiothoracic Vascular and Trasplant Center, IOM, TU
  • Sahid Gangalal Heart Center
  • Bheri Zonal Hospital
  • Manipal College of Medical Sciences
  • Federal Medical Center
  • University of Nigeria Teaching Hospital
  • College of Medicine, University of Ibadan
  • Jos University Teaching Hospital
  • Ahmadu Bello University Teaching Hospital
  • Aminu Kano University Teaching Hospital
  • Department of Medicine, Lagos University Teaching Hospital
  • Ladoke Akintola University of Technology Teaching Hospital
  • Department of Medicine, Delta State University Teaching Hospital
  • Punjab Institute of Cardiology
  • Isra University Hospital
  • Nishtar Hospital Multan
  • Lady Reading Hospital
  • Rawalpindi Institute of Cardiology
  • Instituto Nacional de Cardiología
  • Hospital Barrio Obrero
  • Hospital Regional de Ciudad Del Este
  • Hospital Nacional Itaugua
  • Clinical Hospital
  • Palawan Medical City
  • Philippine General Hospital
  • Philippine Heart Center
  • Quirino Memorial Medical Center
  • University of Rwanda, Kigali University Teaching Hospital
  • Nelson Mandela Academic Hospital
  • Charlotte Maxeke Academic Hospital
  • Sefako Makgatho Health Sciences University
  • Cardiology Research Universitas private hospital
  • University of Cape Town
  • University of Limpopo
  • Port Elizabeth Hospital Complex
  • Chris Hani Baragwanath Hospital
  • Atbara Teaching Hospital
  • Alobeid Teaching Hospital
  • Ahmed Gasim Hospital
  • Alshaab Teaching Hospital
  • Ahmed Gasim Pediatric Hospital
  • Sudan Heart Center
  • Digna Prince Hospital
  • Medani Heart Centre
  • Muhimbili University of Health and Allied Sciences
  • Mbeya Zonal Referral Hospital
  • Uganda Heart Institute
  • Livingstone Central Hospital
  • University Teaching Hospital (UTH)
  • Ndola Central Hospital
  • Mpilo Hospital, National University Science & Technology
  • Harare Hospital
  • Parirenyatwa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban (20 mg)

Vitamin K antagonists (VKA)

Arm Description

Rivaroxaban 20 mg od (n ~ 2250); 15 mg od (once daily) in patients with creatinine clearance (CrCl) 15-49 ml/min

Any approved VKA in the participating country (n ~ 2250); VKA titrated to achieve an INR of 2.0-3.0

Outcomes

Primary Outcome Measures

Time from randomization to the first occurrence of vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
Vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism

Secondary Outcome Measures

Time from randomization to the first occurrence of composite of stroke or systemic embolism
Composite of stroke or systemic embolism

Full Information

First Posted
December 10, 2015
Last Updated
October 3, 2022
Sponsor
Population Health Research Institute
Collaborators
University of Cape Town, Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT02832544
Brief Title
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority
Acronym
INVICTUS-VKA
Official Title
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2016 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
Collaborators
University of Cape Town, Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.
Detailed Description
Non-Inferiority Trial of rivaroxaban versus VKAs: 4,500 patients Inclusion Criteria: RVHD diagnosed by echocardiography at any time prior to enrollment Age ≥18 Increased risk of stroke by any of the following CHA2DS2-VASc score ≥ 2 OR Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR Left atrial spontaneous echo contrast OR Left atrial thrombus Heart Rhythm a) AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram. Treatment: Patients will be randomized either to receive rivaroxaban or any approved VKA. Treatment will be open-label. Rivaroxaban Arm Rivaroxaban 20 mg once daily Rivaroxaban 15 mg once daily (for patients with an creatinine clearance ≥15 and <50 ml/min) VKA Arm Any VKA approved for use in the participating country VKA titrated to achieve an INR of 2.0-3.0

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease
Keywords
atrial fibrillation, stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4565 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban (20 mg)
Arm Type
Experimental
Arm Description
Rivaroxaban 20 mg od (n ~ 2250); 15 mg od (once daily) in patients with creatinine clearance (CrCl) 15-49 ml/min
Arm Title
Vitamin K antagonists (VKA)
Arm Type
Active Comparator
Arm Description
Any approved VKA in the participating country (n ~ 2250); VKA titrated to achieve an INR of 2.0-3.0
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (20 mg)
Other Intervention Name(s)
Xarelto
Intervention Description
Rivaroxaban is non-inferior to VKAs for the prevention of stroke or systemic embolism in patients with AF/flutter and RVHD and potentially superior to VKAs.
Intervention Type
Drug
Intervention Name(s)
Vitamin K antagonists (VKA)
Other Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
Time from randomization to the first occurrence of vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
Description
Vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
Time Frame
Approximately 4 years
Secondary Outcome Measure Information:
Title
Time from randomization to the first occurrence of composite of stroke or systemic embolism
Description
Composite of stroke or systemic embolism
Time Frame
Approximately 4 years
Other Pre-specified Outcome Measures:
Title
Time from randomization to the first occurrence of a Major Bleed
Description
using the ISTH major bleeding definition
Time Frame
Approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: RVHD diagnosed by echocardiography at any time prior to enrollment Age ≥18 Increased risk of stroke by any of the following CHA2DS2-VASc score ≥ 2 OR Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR Left atrial spontaneous echo contrast OR Left atrial thrombus Heart Rhythm *AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram. Exclusion Criteria: Refusal to give informed consent Actively involved in any study that would compromise the protocol of INVICTUS Trial Severe co-morbid condition with life expectancy < 1 year 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. Likely to have valve replacement surgery within 6 months 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. Contraindication to the study medication of the trial Allergy to rivaroxaban Allergy to VKAs ( non-inferiority trial) Allergy to aspirin ( superiority trial) Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15 ml/min Serious bleeding in the past six months or at high risk for bleeding Moderate to severe hepatic impairment Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded) Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor. Received an investigational drug in the past 30 days Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits Women who are pregnant and/or breastfeeding Women of child bearing age who do not use an effective form of birth control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Connolly, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Marina Hospital
City
Gaborone
Country
Botswana
Facility Name
Cardresearch - Cardiologia Assistencial e de Pesquisa
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-240
Country
Brazil
Facility Name
Nucleo de Estudios Clinicos - Universidade Federal do Triângulo Mineiro
City
Uberaba
State/Province
Minas Gerais
Country
Brazil
Facility Name
Eurolatino Pesquisas Médicas Ltda
City
Uberlândia
State/Province
Minas Gerais
ZIP/Postal Code
38411-186
Country
Brazil
Facility Name
Clínica Procardio Ltda.
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-500
Country
Brazil
Facility Name
Instituto de Pesquisa Clínica de Campinas
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
LOEMA - Instituto de Pesquisa Clínica & Consultores Ltda
City
Campinas
ZIP/Postal Code
São Paulo
Country
Brazil
Facility Name
Via Médica Centro Clínico Barroso e Sebba Ltda
City
Goiania
ZIP/Postal Code
74223130
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
ZIP/Postal Code
90620001
Country
Brazil
Facility Name
Fundação Faculdade de Medicina de São José do Rio Preto
City
São José do Rio Preto
ZIP/Postal Code
1509000
Country
Brazil
Facility Name
Instituto do Coração - HCFMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
São Paulo
ZIP/Postal Code
4012909
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Clinique Coeur Et Vie
City
Douala
ZIP/Postal Code
7562
Country
Cameroon
Facility Name
Douala General Hospital
City
Douala
Country
Cameroon
Facility Name
St. Elizabeth Catholic General Hospital, Cardiac Centre
City
Kumbo
Country
Cameroon
Facility Name
Hopital Central Yaounde
City
Yaounde
Country
Cameroon
Facility Name
Liangxiang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102401
Country
China
Facility Name
The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Facility Name
Jixi People's Hospital
City
Jixi
State/Province
Heilongjiang
ZIP/Postal Code
158100
Country
China
Facility Name
Tieli People's Hospital
City
Yichun
State/Province
Heilongjiang
ZIP/Postal Code
152500
Country
China
Facility Name
Luoyang Central's Hospital Affiliated to Zhengzhou University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471009
Country
China
Facility Name
Dancheng County People's Hospital
City
Zhoukou
State/Province
Henan
ZIP/Postal Code
477150
Country
China
Facility Name
Suiping Renan Hospital
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463100
Country
China
Facility Name
Jianshi County People's Hospital
City
Enshi
State/Province
Hubei
ZIP/Postal Code
445308
Country
China
Facility Name
Suqian Peaple's Hospital of Nanjing Drum-Tower Hospital Group
City
Suqian
State/Province
Jiangsu
ZIP/Postal Code
223800
Country
China
Facility Name
Tonghua Central Hospital
City
Tonghua
State/Province
Jilin
ZIP/Postal Code
134001
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Ningxia Peple's Hospital
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750021
Country
China
Facility Name
Pi County People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611730
Country
China
Facility Name
Anyue County People's Hospital
City
Ziyang
State/Province
Sichuan
ZIP/Postal Code
642350
Country
China
Facility Name
Wendeng Central Hospital
City
Weihai
State/Province
Wendeng
Country
China
Facility Name
Ninghai People's Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315600
Country
China
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Zhongmou County People's Hospital
City
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Zhengzhou No.7 People's Hospital
City
Henan
ZIP/Postal Code
450016
Country
China
Facility Name
Zhengzhou 9th People's Hospital
City
Henan
ZIP/Postal Code
450053
Country
China
Facility Name
Guangshan County People's Hospital
City
Henan
Country
China
Facility Name
Alexandria University Hospital
City
Alexandria
ZIP/Postal Code
21561
Country
Egypt
Facility Name
Assuit General Hospital
City
Assuit
Country
Egypt
Facility Name
Benha University Cardiology Department
City
Banha
Country
Egypt
Facility Name
Beni Suef University Hospital
City
Banī Suwayf
Country
Egypt
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
Kasr El Einy Hospital (Cairo University)
City
Cairo
ZIP/Postal Code
21561
Country
Egypt
Facility Name
Mehallah Rheumatic Heart Center
City
El Mansura
ZIP/Postal Code
31951
Country
Egypt
Facility Name
Specialized Medical Hospital - Mansoura
City
El Mansura
ZIP/Postal Code
35516
Country
Egypt
Facility Name
Fayoum General Hospital
City
Fayoum
ZIP/Postal Code
31951
Country
Egypt
Facility Name
Suez Canal University Hospital
City
Ismailia
ZIP/Postal Code
41522
Country
Egypt
Facility Name
El Minia University Hospital
City
Minya
ZIP/Postal Code
61519
Country
Egypt
Facility Name
Sohag University, Sohag
City
Sohag
ZIP/Postal Code
35516
Country
Egypt
Facility Name
Red Crescent Hospital
City
Tanta
ZIP/Postal Code
31951
Country
Egypt
Facility Name
Zagazig University Hospital
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt
Facility Name
Hawassa University Referral Hospital
City
Hawassa
State/Province
Snnpr
Country
Ethiopia
Facility Name
College of Health Sciences, Addis Ababa University, Black Lion Hospital
City
Addis Ababa
ZIP/Postal Code
1176
Country
Ethiopia
Facility Name
Jimma University Hospital
City
Jimma
Country
Ethiopia
Facility Name
Mekelle University
City
Mek'ele
ZIP/Postal Code
1871
Country
Ethiopia
Facility Name
Dr. Ram Manohar Lohia Hospital @ PGIMER
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Govind Ballabh Pant Hospital (GIPMER)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sri Jayadev Institute of Cardiovascular Sciences and Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560069
Country
India
Facility Name
SMS Medical College
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
King George's Medical College
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Sanjay Gandhi Post Graduate Institute of Medical Sciences
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
Kazakh National Medical Institute,
City
Almaty
Country
Kazakhstan
Facility Name
Moi Teaching and Referral Hospital
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Facility Name
Karen Hospital
City
Nairobi
ZIP/Postal Code
00200
Country
Kenya
Facility Name
Kenyatta National Hospital / University Of Nairobi
City
Nairobi
Country
Kenya
Facility Name
Clinical Hospital of administrative department of President and Government of Kyrgyz Republic
City
Bishkek
ZIP/Postal Code
720001
Country
Kyrgyzstan
Facility Name
Queen Elizabeth Central Hospital
City
Blantyre
ZIP/Postal Code
265
Country
Malawi
Facility Name
Kumuzu Central Hospital
City
Lilongwe
ZIP/Postal Code
265
Country
Malawi
Facility Name
Mzuzu Central Hospital
City
Mzuzu
ZIP/Postal Code
265
Country
Malawi
Facility Name
Hospital Angeles León
City
León
State/Province
Guanajuato
ZIP/Postal Code
37150
Country
Mexico
Facility Name
Hospital Bernardette
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Centro de Estudios Clínicos de Querétaro S.C.
City
Queretaro
State/Province
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Centro para el Desarrollo de la Medicina y Asistencia Especializada S.C.
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Instituto de Investigación del Hospital Cardiológica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital General Dr. Jorge Soberon Acevedo.Secretaria de Salud del Estado de Guerrero
City
Guerrero
ZIP/Postal Code
40000
Country
Mexico
Facility Name
Instituto Nacional de Cardiología Ignacio Chavez
City
México
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Maputo Central Hospital
City
Maputo
ZIP/Postal Code
1111
Country
Mozambique
Facility Name
Instituto Nacional de Saude & Universidade Eduardo Mondlane
City
Maputo
ZIP/Postal Code
CP 264
Country
Mozambique
Facility Name
College of Medical Sciences
City
Bharatpur
ZIP/Postal Code
44207
Country
Nepal
Facility Name
Chitwan Medical College
City
Bharatpur
Country
Nepal
Facility Name
Nobel medical college and teaching hospital pvt ltd
City
Biratnagar
ZIP/Postal Code
56613
Country
Nepal
Facility Name
Gautam Buddha Community Heart Hospital
City
Butwal
ZIP/Postal Code
32907
Country
Nepal
Facility Name
BP Koirala Institute of Health Sciences
City
Dharān Bāzār
ZIP/Postal Code
56700
Country
Nepal
Facility Name
Manmohan Cardiothoracic Vascular and Trasplant Center, IOM, TU
City
Kathmandu
ZIP/Postal Code
44600
Country
Nepal
Facility Name
Sahid Gangalal Heart Center
City
Kathmandu
ZIP/Postal Code
44600
Country
Nepal
Facility Name
Bheri Zonal Hospital
City
Nepalgunj
ZIP/Postal Code
21900
Country
Nepal
Facility Name
Manipal College of Medical Sciences
City
Pokhara
ZIP/Postal Code
33700
Country
Nepal
Facility Name
Federal Medical Center
City
Abeokuta
Country
Nigeria
Facility Name
University of Nigeria Teaching Hospital
City
Enugu
ZIP/Postal Code
400201
Country
Nigeria
Facility Name
College of Medicine, University of Ibadan
City
Ibadan
ZIP/Postal Code
200212
Country
Nigeria
Facility Name
Jos University Teaching Hospital
City
Jos
ZIP/Postal Code
930001
Country
Nigeria
Facility Name
Ahmadu Bello University Teaching Hospital
City
Kaduna
ZIP/Postal Code
810001
Country
Nigeria
Facility Name
Aminu Kano University Teaching Hospital
City
Kano
ZIP/Postal Code
700223
Country
Nigeria
Facility Name
Department of Medicine, Lagos University Teaching Hospital
City
Lagos
ZIP/Postal Code
12003
Country
Nigeria
Facility Name
Ladoke Akintola University of Technology Teaching Hospital
City
Ogbomoso
ZIP/Postal Code
4007
Country
Nigeria
Facility Name
Department of Medicine, Delta State University Teaching Hospital
City
Oghara
Country
Nigeria
Facility Name
Punjab Institute of Cardiology
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
Isra University Hospital
City
Hyderabad
ZIP/Postal Code
31300
Country
Pakistan
Facility Name
Nishtar Hospital Multan
City
Multan
ZIP/Postal Code
60000
Country
Pakistan
Facility Name
Lady Reading Hospital
City
Peshawar
ZIP/Postal Code
PK 2500
Country
Pakistan
Facility Name
Rawalpindi Institute of Cardiology
City
Rawalpindi
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Instituto Nacional de Cardiología
City
Asunción
ZIP/Postal Code
1725
Country
Paraguay
Facility Name
Hospital Barrio Obrero
City
Asunción
ZIP/Postal Code
2279
Country
Paraguay
Facility Name
Hospital Regional de Ciudad Del Este
City
Ciudad del Este
ZIP/Postal Code
7000
Country
Paraguay
Facility Name
Hospital Nacional Itaugua
City
Itaugua
ZIP/Postal Code
2740
Country
Paraguay
Facility Name
Clinical Hospital
City
San Lorenzo
ZIP/Postal Code
1863
Country
Paraguay
Facility Name
Palawan Medical City
City
Puerto Princesa City
State/Province
Palawan
ZIP/Postal Code
5300
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Philippine Heart Center
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Quirino Memorial Medical Center
City
Quezon City
ZIP/Postal Code
1109
Country
Philippines
Facility Name
University of Rwanda, Kigali University Teaching Hospital
City
Kigali
Country
Rwanda
Facility Name
Nelson Mandela Academic Hospital
City
Mthatha
State/Province
Eastern Cape
ZIP/Postal Code
5099
Country
South Africa
Facility Name
Charlotte Maxeke Academic Hospital
City
Johannesburg
State/Province
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Sefako Makgatho Health Sciences University
City
Ga-Rankuwa,
State/Province
Pretoria
ZIP/Postal Code
0204
Country
South Africa
Facility Name
Cardiology Research Universitas private hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
University of Cape Town
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
University of Limpopo
City
Polokwane
ZIP/Postal Code
700
Country
South Africa
Facility Name
Port Elizabeth Hospital Complex
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Atbara Teaching Hospital
City
Atbara
Country
Sudan
Facility Name
Alobeid Teaching Hospital
City
El Obeid
Country
Sudan
Facility Name
Ahmed Gasim Hospital
City
Khartoum
ZIP/Postal Code
1111
Country
Sudan
Facility Name
Alshaab Teaching Hospital
City
Khartoum
ZIP/Postal Code
1111
Country
Sudan
Facility Name
Ahmed Gasim Pediatric Hospital
City
Khartoum
Country
Sudan
Facility Name
Sudan Heart Center
City
Khartoum
Country
Sudan
Facility Name
Digna Prince Hospital
City
Port Sudan
Country
Sudan
Facility Name
Medani Heart Centre
City
Wad Medani
Country
Sudan
Facility Name
Muhimbili University of Health and Allied Sciences
City
Dar es Salaam
Country
Tanzania
Facility Name
Mbeya Zonal Referral Hospital
City
Mbeya
ZIP/Postal Code
419
Country
Tanzania
Facility Name
Uganda Heart Institute
City
Kampala
Country
Uganda
Facility Name
Livingstone Central Hospital
City
Livingstone
ZIP/Postal Code
10101
Country
Zambia
Facility Name
University Teaching Hospital (UTH)
City
Lusaka
Country
Zambia
Facility Name
Ndola Central Hospital
City
Ndola
ZIP/Postal Code
10101
Country
Zambia
Facility Name
Mpilo Hospital, National University Science & Technology
City
Bulawayo
Country
Zimbabwe
Facility Name
Harare Hospital
City
Harare
Country
Zimbabwe
Facility Name
Parirenyatwa Hospital
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
cumulative participant data only
Citations:
PubMed Identifier
36036525
Citation
Connolly SJ, Karthikeyan G, Ntsekhe M, Haileamlak A, El Sayed A, El Ghamrawy A, Damasceno A, Avezum A, Dans AML, Gitura B, Hu D, Kamanzi ER, Maklady F, Fana G, Gonzalez-Hermosillo JA, Musuku J, Kazmi K, Zuhlke L, Gondwe L, Ma C, Paniagua M, Ogah OS, Molefe-Baikai OJ, Lwabi P, Chillo P, Sharma SK, Cabral TTJ, Tarhuni WM, Benz A, van Eikels M, Krol A, Pattath D, Balasubramanian K, Rangarajan S, Ramasundarahettige C, Mayosi B, Yusuf S; INVICTUS Investigators. Rivaroxaban in Rheumatic Heart Disease-Associated Atrial Fibrillation. N Engl J Med. 2022 Sep 15;387(11):978-988. doi: 10.1056/NEJMoa2209051. Epub 2022 Aug 28.
Results Reference
derived
PubMed Identifier
33136507
Citation
Karthikeyan G, Connolly SJ, Yusuf S. Overestimation of Stroke Risk in Rheumatic Mitral Stenosis and the Implications for Oral Anticoagulation. Circulation. 2020 Nov 3;142(18):1697-1699. doi: 10.1161/CIRCULATIONAHA.120.050347. Epub 2020 Nov 2. No abstract available. Erratum In: Circulation. 2023 Feb 21;147(8):e623.
Results Reference
derived
PubMed Identifier
32474206
Citation
Karthikeyan G, Connolly SJ, Ntsekhe M, Benz A, Rangarajan S, Lewis G, Yun Y, Sharma SK, Maklady F, Elghamrawy AE, Kazmi K, Cabral TTJ, Dayi H, Changsheng M, Gitura BM, Avezum A, Zuhlke L, Lwabi P, Haileamlak A, Ogah O, Chillo P, Paniagua M, ElSayed A, Dans A, Gondwe-Chunda L, Molefe-Baikai OJ, Gonzalez-Hermosillo JA, Hakim J, Damasceno A, Kamanzi ER, Musuku J, Davletov K, Connolly K, Mayosi BM, Yusuf S; INVICTUS Investigators. The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation. Am Heart J. 2020 Jul;225:69-77. doi: 10.1016/j.ahj.2020.03.018. Epub 2020 Mar 25.
Results Reference
derived

Learn more about this trial

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

We'll reach out to this number within 24 hrs