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

PHASE3CompletedINTERVENTIONAL
Enrollment

4,565

Participants

Timeline

Start Date

August 22, 2016

Primary Completion Date

August 18, 2022

Study Completion Date

August 18, 2022

Conditions
Rheumatic Heart Disease
Interventions
DRUG

Rivaroxaban (20 mg)

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.

DRUG

Vitamin K antagonists (VKA)

Trial Locations (139)

265

Queen Elizabeth Central Hospital, Blantyre

Kumuzu Central Hospital, Lilongwe

Mzuzu Central Hospital, Mzuzu

419

Mbeya Zonal Referral Hospital, Mbeya

700

University of Limpopo, Polokwane

1000

Philippine General Hospital, Manila

1100

Philippine Heart Center, Quezon City

1109

Quirino Memorial Medical Center, Quezon City

1111

Maputo Central Hospital, Maputo

Ahmed Gasim Hospital, Khartoum

Alshaab Teaching Hospital, Khartoum

1176

College of Health Sciences, Addis Ababa University, Black Lion Hospital, Addis Ababa

1725

Instituto Nacional de Cardiología, Asunción

1863

Clinical Hospital, San Lorenzo

1871

Mekelle University, Mek'ele

2013

Chris Hani Baragwanath Hospital, Soweto

2193

Charlotte Maxeke Academic Hospital, Johannesburg

2279

Hospital Barrio Obrero, Asunción

2740

Hospital Nacional Itaugua, Itauguá

4007

Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso

5099

Nelson Mandela Academic Hospital, Mthatha

5300

Palawan Medical City, Puerto Princesa City

6001

Port Elizabeth Hospital Complex, Port Elizabeth

7000

Hospital Regional de Ciudad Del Este, Ciudad del Este

7562

Clinique Coeur Et Vie, Douala

7925

University of Cape Town, Cape Town

9301

Cardiology Research Universitas private hospital, Bloemfontein

10101

Livingstone Central Hospital, Livingstone

Ndola Central Hospital, Ndola

11566

Ain Shams University Hospital, Cairo

12003

Department of Medicine, Lagos University Teaching Hospital, Lagos

14080

Instituto Nacional de Cardiología Ignacio Chavez, México

20230

Instituto de Investigación del Hospital Cardiológica Aguascalientes, Aguascalientes

21561

Alexandria University Hospital, Alexandria

Kasr El Einy Hospital (Cairo University), Cairo

21900

Bheri Zonal Hospital, Nepalgunj

30100

Moi Teaching and Referral Hospital, Eldoret

31300

Isra University Hospital, Hyderābād

31951

Fayoum General Hospital, Al Fayyum

Mehallah Rheumatic Heart Center, Al Mansurah

Red Crescent Hospital, Tanta

32907

Gautam Buddha Community Heart Hospital, Butwāl

33700

Manipal College of Medical Sciences, Pokhara

35516

Specialized Medical Hospital - Mansoura, Al Mansurah

Sohag University, Sohag, Sohag

37150

Hospital Angeles León, León

40000

Hospital General Dr. Jorge Soberon Acevedo.Secretaria de Salud del Estado de Guerrero, Guerrero

41522

Suez Canal University Hospital, Ismailia

44200

Hospital Bernardette, Guadalajara

44207

College of Medical Sciences, Bharatpur

44519

Zagazig University Hospital, Zagazig

44600

Manmohan Cardiothoracic Vascular and Trasplant Center, IOM, TU, Kathmandu

Sahid Gangalal Heart Center, Kathmandu

46000

Rawalpindi Institute of Cardiology, Rawalpindi

54000

Punjab Institute of Cardiology, Lahore

56613

Nobel medical college and teaching hospital pvt ltd, Biratnagar

56700

BP Koirala Institute of Health Sciences, Dharān

60000

Nishtar Hospital Multan, Multan

61519

El Minia University Hospital, Minya

76000

Centro de Estudios Clínicos de Querétaro S.C., Querétaro City

80230

Centro para el Desarrollo de la Medicina y Asistencia Especializada S.C., Culiacán

100029

Beijing Anzhen Hospital, Beijing

102401

Liangxiang Hospital, Beijing

110001

Dr. Ram Manohar Lohia Hospital @ PGIMER, New Delhi

110002

Govind Ballabh Pant Hospital (GIPMER), New Delhi

110029

All India Institute of Medical Sciences, New Delhi

116001

Affiliated Zhongshan Hospital of Dalian University, Dalian

116011

The First Affiliated Hospital of Dalian Medical University, Dalian

134001

Tonghua Central Hospital, Tonghua

152500

Tieli People's Hospital, Yichun

158100

Jixi People's Hospital, Jixi

200212

College of Medicine, University of Ibadan, Ibadan

223800

Suqian Peaple's Hospital of Nanjing Drum-Tower Hospital Group, Suqian

226003

King George's Medical College, Lucknow

226014

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

302004

SMS Medical College, Jaipur

315600

Ninghai People's Hospital, Ningbo

400201

University of Nigeria Teaching Hospital, Enugu

445308

Jianshi County People's Hospital, Enshi

450000

Zhongmou County People's Hospital, Henan

450016

Zhengzhou No.7 People's Hospital, Henan

450053

Zhengzhou 9th People's Hospital, Henan

463100

Suiping Renan Hospital, Zhumadian

471009

Luoyang Central's Hospital Affiliated to Zhengzhou University, Luoyang

477150

Dancheng County People's Hospital, Zhoukou

510062

The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University, Guangzhou

560069

Sri Jayadev Institute of Cardiovascular Sciences and Research, Bangalore

611730

Pi County People's Hospital, Chengdu

642350

Anyue County People's Hospital, Ziyang

700223

Aminu Kano University Teaching Hospital, Kano

720001

Clinical Hospital of administrative department of President and Government of Kyrgyz Republic, Bishkek

750021

Ningxia Peple's Hospital, Yinchuan

810001

Ahmadu Bello University Teaching Hospital, Kaduna

930001

Jos University Teaching Hospital, Jos

1509000

Fundação Faculdade de Medicina de São José do Rio Preto, São José do Rio Preto

4012909

Instituto Dante Pazzanese de Cardiologia, São Paulo

74223130

Via Médica Centro Clínico Barroso e Sebba Ltda, Goiânia

90620001

Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre

Unknown

Princess Marina Hospital, Gaborone

Nucleo de Estudios Clinicos - Universidade Federal do Triângulo Mineiro, Uberaba

Douala General Hospital, Douala

St. Elizabeth Catholic General Hospital, Cardiac Centre, Kumbo

Hopital Central Yaounde, Yaoundé

Wendeng Central Hospital, Weihai

Guangshan County People's Hospital, Henan

Assuit General Hospital, Asyut

Benha University Cardiology Department, Banhā

Beni Suef University Hospital, Banī Suwayf

Hawassa University Referral Hospital, Awasa

Jimma University Hospital, Jimma

Kazakh National Medical Institute,, Almaty

Kenyatta National Hospital / University Of Nairobi, Nairobi

Chitwan Medical College, Bharatpur

Federal Medical Center, Abeokuta

Department of Medicine, Delta State University Teaching Hospital, Oghara

University of Rwanda, Kigali University Teaching Hospital, Kigali

Alobeid Teaching Hospital, Al-Ubayyid

Atbara Teaching Hospital, Atbara

Ahmed Gasim Pediatric Hospital, Khartoum

Sudan Heart Center, Khartoum

Digna Prince Hospital, Port Sudan

Medani Heart Centre, Wad Medani

Muhimbili University of Health and Allied Sciences, Dar es Salaam

Uganda Heart Institute, Kampala

University Teaching Hospital (UTH), Lusaka

Mpilo Hospital, National University Science & Technology, Bulawayo

Harare Hospital, Harare

Parirenyatwa Hospital, Harare

30150-240

Cardresearch - Cardiologia Assistencial e de Pesquisa, Belo Horizonte

38411-186

Eurolatino Pesquisas Médicas Ltda, Uberlândia

89010-500

Clínica Procardio Ltda., Blumenau

13060-080

Instituto de Pesquisa Clínica de Campinas, Campinas

São Paulo

LOEMA - Instituto de Pesquisa Clínica & Consultores Ltda, Campinas

05403-000

Instituto do Coração - HCFMUSP, São Paulo

15500-003

Santa Casa de Misericórdia de Votuporanga, Votuporanga

00200

Karen Hospital, Nairobi

CP 264

Instituto Nacional de Saude & Universidade Eduardo Mondlane, Maputo

PK 2500

Lady Reading Hospital, Peshawar

0204

Sefako Makgatho Health Sciences University, Ga-Rankuwa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Cape Town

OTHER

collaborator

Bayer

INDUSTRY

lead

Population Health Research Institute

OTHER