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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02832544
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
University of Cape Town
Bayer
Information provided by (Responsible Party):
Population Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Rheumatic Heart Disease Drug: Rivaroxaban (20 mg) Drug: Vitamin K antagonists (VKA) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
Actual Study Start Date : August 22, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Rivaroxaban (20 mg)
Rivaroxaban 20 mg od (n ~ 2250); 15 mg od (once daily) in patients with creatinine clearance (CrCl) 15-49 ml/min
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.
Other Name: Xarelto

Active Comparator: Vitamin K antagonists (VKA)
Any approved VKA in the participating country (n ~ 2250); VKA titrated to achieve an INR of 2.0-3.0
Drug: Vitamin K antagonists (VKA)
Other Name: Warfarin




Primary Outcome Measures :
  1. Time from randomization to the first occurrence of Stroke or Systemic Embolism [ Time Frame: Approximately 4 years ]
    Stroke (Ischemic, hemorrhagic or undetermined type)


Secondary Outcome Measures :
  1. Time from randomization to the first occurrence of Myocardial Infarction (MI) [ Time Frame: Approximately 4 years ]
  2. Time from randomization to time of vascular death [ Time Frame: Approximately 4 years ]
    Vascular death includes death due to stroke, myocardial infarction, heart failure or cardiogenic shock, sudden death or any other death due to cardiovascular causes. In addition, death due to hemorrhage will be included


Other Outcome Measures:
  1. Time from randomization to the first occurrence of a Major Bleed [ Time Frame: Approximately 4 years ]
    using the ISTH major bleeding definition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832544


Contacts
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Contact: Gayle D Lewis 1-866-414-7474 gayle.lewis@phri.ca
Contact: Sumathy Rangarajan, MSc 1-866-414-7474 sumathy.rangarajan@phri.ca

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Locations
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Botswana
Princess Marina Hospital Recruiting
Gaborone, Botswana
Contact: Onkabetse Julia Molefe-Baikai    267-72492039 / 267-3621400    onksmolf@yahoo.com   
Brazil
Cardresearch - Cardiologia Assistencial e de Pesquisa Active, not recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-240
Nucleo de Estudios Clinicos - Universidade Federal do Triângulo Mineiro Active, not recruiting
Uberaba, Minas Gerais, Brazil
Eurolatino Pesquisas Médicas Ltda Active, not recruiting
Uberlândia, Minas Gerais, Brazil, 38411-186
Clínica Procardio Ltda. Recruiting
Blumenau, Santa Catarina, Brazil, 89010-500
Contact: Sérgio Luiz Zimmermann    55 47 999851322    slzimmermann@cardioblu.com.br   
Instituto de Pesquisa Clínica de Campinas Recruiting
Campinas, Brazil, 13060-080
Contact: José Francisco Kerr Saraiva    19 9 96015550    jfsaraiva@uol.com.br   
LOEMA - Instituto de Pesquisa Clínica & Consultores Ltda Recruiting
Campinas, Brazil, São Paulo
Contact: Fabio Rossi dos Santos    +55 19 998096000    fabio.rossi@loemaipc.com.br   
Via Médica Centro Clínico Barroso e Sebba Ltda Active, not recruiting
Goiania, Brazil, 74223130
Instituto de Cardiologia do Rio Grande do Sul Active, not recruiting
Porto Alegre, Brazil, 90620001
Fundação Faculdade de Medicina de São José do Rio Preto Active, not recruiting
São José do Rio Preto, Brazil, 1509000
Instituto do Coração - HCFMUSP Recruiting
São Paulo, Brazil, 05403-000
Contact: Flavio Tarasoutchi    +55 (11) 999328767    tarasout@uol.com.br   
Instituto Dante Pazzanese de Cardiologia Recruiting
São Paulo, Brazil, 4012909
Contact: Auristela Ramos    55-11-996296961    drauri.ramos@hotmail.com   
Santa Casa de Misericórdia de Votuporanga Recruiting
Votuporanga, Brazil, 15500-003
Contact: Mauro Hernandes    5517991459465    unipec@santacasavotuporanga.com.br   
Cameroon
Clinique Coeur Et Vie Recruiting
Douala, Cameroon, 7562
Contact: DJOMOU NGONGANG FLORENT ARMEL    237651117187    drdjomouarmel@yahoo.fr   
Douala General Hospital Recruiting
Douala, Cameroon
Contact: Anastase Dzudie    237 679617981    aitdzudie@yahoo.com   
St. Elizabeth Catholic General Hospital, Cardiac Centre Recruiting
Kumbo, Cameroon
Contact: Tantchou Tchoumi Jacques Cabral    237 699323742    tantchouj@yahoo.fr   
Hopital Central Yaounde Recruiting
Yaounde, Cameroon
Contact: Ntep Gweth Ngo Youmba    699668692    mmentep@justice.com   
China, Beijing
Liangxiang Hospital Recruiting
Beijing, Beijing, China, 102401
Contact: Yu Qing    13911551534    yuqing6508@hotmail.com   
China, Guangdong
The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University Recruiting
Guangzhou, Guangdong, China, 510062
Contact: Wei Zhang    13610330852    zhangweitlyy@126.com   
Sun Yat-Sen Cardiovascular Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518112
Contact: Zhang Huijie    13924633978      
China, Hebei
Shunping Xinghe Hospital Withdrawn
Baoding, Hebei, China, 72250
China, Heilongjiang
Jixi People's Hospital Recruiting
Jixi, Heilongjiang, China, 158100
Contact: Xie Sitao    15146763650    66997398@qq.com   
Tieli People's Hospital Recruiting
Yichun, Heilongjiang, China, 152500
Contact: Niu Yanbo    13134587500    13134587500@163.com   
China, Henan
Luoyang Central's Hospital Affiliated to Zhengzhou University Recruiting
Luoyang, Henan, China, 471009
Contact: Zhang Shouyan    13938801812    zysdoctor@163.com   
Puyang Oilfield General Hospital Not yet recruiting
Puyang, Henan, China, 457001
Contact: Wang Hengliang         
Dancheng County People's Hospital Recruiting
Zhoukou, Henan, China, 477150
Contact: Guo Hunayu    13592229900    13592229900@139.com   
Suiping Renan Hospital Recruiting
Zhumadian, Henan, China, 463100
Contact: Sun Jinpo    13839941874    404209187@qq.com   
China, Hubei
Jianshi County People's Hospital Recruiting
Enshi, Hubei, China, 445308
Contact: Ma Mingfu    13997795565    15389676@qq.com   
China, Jiangsu
Suqian Peaple's Hospital of Nanjing Drum-Tower Hospital Group Recruiting
Suqian, Jiangsu, China, 223800
Contact: Hao Ding    18012186826    haoding69@sohu.com   
China, Jilin
Tonghua Central Hospital Recruiting
Tonghua, Jilin, China, 134001
Contact: Wang Shudong    13944592198    xianfeng2198@qq.com   
China, Liaoning
Affiliated Zhongshan Hospital of Dalian University Recruiting
Dalian, Liaoning, China, 116001
Contact: Wang Xiaomei    1 359 1384353    Wangxiaomei0428@163.com   
The First Affiliated Hospital of Dalian Medical University Active, not recruiting
Dalian, Liaoning, China, 116011
China, Ningxia
Ningxia Peple's Hospital Recruiting
Yinchuan, Ningxia, China, 750021
Contact: Luan Hong    18408406559    lifu505@163.com   
China, Shanxi
Xi'an Chang'an Hospital Withdrawn
Xi'an, Shanxi, China, 710100
China, Sichuan
Pi County People's Hospital Recruiting
Chengdu, Sichuan, China, 611730
Contact: Yu Chaoping    13438471846    53260837@qq.com   
Anyue County People's Hospital Recruiting
Ziyang, Sichuan, China, 642350
Contact: Xu Yongbin    13708260302    21858141@qq.com   
China, Wendeng
Wendeng Central Hospital Recruiting
Weihai, Wendeng, China
Contact: Jinguo Zhao    135 6185 2177    zjg52177@163.com   
China, Zhejiang
Ninghai People's Hospital Recruiting
Ningbo, Zhejiang, China, 315600
Contact: Wang Xiaoying    15906562636    wangxiaonbip@163.com   
China
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Contact: Ma Changsheng    13901357404    chshma@vip.sina.com   
Zhongmou County People's Hospital Recruiting
Henan, China, 450000
Contact: Kong Xiuzhen    13663851005    kxzys@126.com   
Zhengzhou No.7 People's Hospital Recruiting
Henan, China, 450016
Contact: Yuan Yiqiang    13838125038    zzqyyuanyiqiang@126.com   
The 1st Affiliated Hospital of Zhengzhou University Withdrawn
Henan, China, 450052
Zhengzhou 9th People's Hospital Recruiting
Henan, China, 450053
Contact: Zhao Mingzhong    15038360018    jymzzhao@163.com   
Guangshan County People's Hospital Recruiting
Henan, China
Contact: Wang Qi    18537682099    hngswq99@163.com   
Wuhan No. 1 Hospital Not yet recruiting
Wuhan, China, 430022
Contact: Liqun He    137 2021 0083    1260239989@qq.com   
Egypt
Alexandria University Hospital Recruiting
Alexandria, Egypt, 21561
Contact: Aly Ahmed Abu Al Huda    002-01226604971    aly.aboelhoda@gmail.com   
Assuit General Hospital Recruiting
Assuit, Egypt
Contact: Khalid Mohamed Eltamawey    002-01002867610    khalid_eltamawey@yahoo.com   
Benha University Cardiology Department Recruiting
Banha, Egypt
Contact: Osama Sanad    1223316682    osamasanad@hotmail.com   
Beni Suef University Hospital Active, not recruiting
Beni Suef, Egypt
Ain Shams University Hospital Recruiting
Cairo, Egypt, 11566
Contact: Sameh Shahine    02-224024111    samehshaheen@gmail.com   
Kasr El Einy Hospital (Cairo University) Recruiting
Cairo, Egypt, 21561
Contact: Sulaiman Gharib    01006002668    drsoliman720@gmail.com   
Mehallah Rheumatic Heart Center Recruiting
El Mahalla El Kubra, Egypt, 31951
Contact: Alaa Elghamrawi    1001834994    alaaelghamrawy@yahoo.com   
Specialized Medical Hospital - Mansoura Recruiting
El Mansura, Egypt, 35516
Contact: Mahmoud Youssif    002-01005290606    myousif200@gmail.com   
Fayoum General Hospital Recruiting
Fayoum, Egypt, 31951
Contact: Ramadan Ahmed    1067773573    singlegy2000@yahoo.com   
National Heart Institute Not yet recruiting
Giza, Egypt, 31951
Contact: Mohamed Helmi    02-233025022    helmyegypt2004@yahoo.com   
Suez Canal University Hospital Recruiting
Ismailia, Egypt, 41522
Contact: Omar Mohamed Saleh    002-01006777612    egyomar@yahoo.com   
El Minia University Hospital Recruiting
Minya, Egypt, 61519
Contact: El Alaa Ibrahim    20114381172200201222196084    alaamiali@msn.com   
Sohag University, Sohag Recruiting
Sohag, Egypt, 35516
Contact: Aly Mahmood Kassem    093-4600526    alikasse@gmail.com   
Red Crescent Hospital Active, not recruiting
Tanta, Egypt, 31951
Zagazig University Hospital Active, not recruiting
Zagazig, Egypt, 44519
Ethiopia
Hawassa University Referral Hospital Active, not recruiting
Hawassa, Snnpr, Ethiopia
College of Health Sciences, Addis Ababa University, Black Lion Hospital Active, not recruiting
Addis Ababa, Ethiopia, 1176
Gondar University Hospital Withdrawn
Gondar, Ethiopia
Jimma University Hospital Active, not recruiting
Jimma, Ethiopia
Mekelle University Active, not recruiting
Mekelle, Ethiopia, 1871
India
Dr. Ram Manohar Lohia Hospital @ PGIMER Recruiting
New Delhi, Delhi, India, 110001
Contact: Ranjit Nath    9971138171    ranjitknath@yahoo.com   
Govind Ballabh Pant Hospital (GIPMER) Recruiting
New Delhi, Delhi, India, 110002
Contact: Mohit Gupta    91-9871062464    drmohitgupta@yahoo.com   
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: G. Karthikeyan    91-9871074832    karthik2010@gmail.com   
Sri Jayadev Institute of Cardiovascular Sciences and Research Recruiting
Bangalore, Karnataka, India, 560069
Contact: C. N. Manjunath    919663554483    drcnmanjunath@gmail.com   
SMS Medical College Not yet recruiting
Jaipur, Rajasthan, India, 302004
Contact: Chandra Bhan Meena    9414250934    drcbhan@gmail.com   
King George's Medical College Recruiting
Lucknow, Uttar Pradesh, India, 226003
Contact: Rishi Sethi    9415085717    drrishisethi1@gmail.com   
Sanjay Gandhi Post Graduate Institute of Medical Sciences Recruiting
Lucknow, Uttar Pradesh, India, 226014
Contact: Sudeep Kumar    91-9919002761    sudeepkum@yahoo.com   
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Parag Barwad    91-8968732470    paragaims@gmail.com   
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) Not yet recruiting
Pondicherry, India, 605006
Contact: Santhosh Satheesh    9443426244    drsanthoshsatheesh@gmail.com   
Kazakhstan
Kazakh National Medical Institute, Not yet recruiting
Almaty, Kazakhstan
Contact: Kairat Davletov    772723301037705625 1730    davletovkairat@gmail.com   
Kenya
Moi Teaching and Referral Hospital Recruiting
Eldoret, Kenya, 30100
Contact: Ayub Felix Barasa    254 723 174 268    barasaceo12@gmail.com   
Karen Hospital Recruiting
Nairobi, Kenya, 00200
Contact: Anthony Gikonyo    700535280    anthony.gikonyo@karenhospital.org   
The Mater Hospital Withdrawn
Nairobi, Kenya, 254
Aga Khan University Hospital Withdrawn
Nairobi, Kenya, 623
Kenyatta National Hospital / University Of Nairobi Recruiting
Nairobi, Kenya
Contact: Elijah Ogola    254 20 2725452    enogola@hotmail.com   
Kyrgyzstan
Clinical Hospital of administrative department of President and Government of Kyrgyz Republic Not yet recruiting
Bishkek, Kyrgyzstan, 720001
Contact: Gulmira Baitova    996 550 796883    baitovagm@mail.ru   
National Center of Cardiology and Internal Diseases Not yet recruiting
Bishkek, Kyrgyzstan, 720040
Contact: Nazgul Omurzakova    996-556-555911    omurzakova.nazgul@gmail.com   
Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi, 265
Contact: Tamara Phiri         
Kumuzu Central Hospital Recruiting
Lilongwe, Malawi, 265
Contact: Lillian Gondwe-Chunda    265997614090    lilliangondwe@yahoo.co.uk   
Mzuzu Central Hospital Recruiting
Mzuzu, Malawi, 265
Contact: Frank Sinyiza    265885554425    frasinyiza@yahoo.com   
Mexico
Hospital Angeles León Active, not recruiting
León, Guanajuato, Mexico, 37150
Hospital General De Acapulco Not yet recruiting
Acapulco, Guerrero, Mexico, 39570
Contact: Norberto Matadamas    5217441745015    matadamashn@hotmail.com   
Hospital General Dr. Jorge Soberon Acevedo.Secretaria de Salud del Estado de Guerrero Active, not recruiting
Iguala, Guerrero, Mexico, 40000
Hospital Bernardette Active, not recruiting
Guadalajara, Jalisco, Mexico, 44200
Centro de Estudios Clínicos de Querétaro S.C. Active, not recruiting
Queretaro, Querétaro, Mexico, 76000
Centro para el Desarrollo de la Medicina y Asistencia Especializada S.C. Active, not recruiting
Culiacan, Sinaloa, Mexico, 80230
Instituto de Investigación del Hospital Cardiológica Aguascalientes Active, not recruiting
Aguascalientes, Mexico, 20230
Universidad Nacional Autónoma de México. Hospital General de México Not yet recruiting
Mexico City, Mexico, 1020
Contact: Luis Molina    52 1 55 5413 8711    lmolina@unam.mx   
Instituto Nacional de Cardiología Ignacio Chavez Active, not recruiting
México, Mexico, 14080
Mozambique
Maputo Central Hospital Recruiting
Maputo, Mozambique, 1111
Contact: Albertino Damasceno    258 823061160    tino_7117@yahoo.com.br   
Instituto Nacional de Saude & Universidade Eduardo Mondlane Recruiting
Maputo, Mozambique, CP 264
Contact: Ana Mocumbi    258 82 3294990    amocumbi@gmail.com   
Nepal
College of Medical Sciences Recruiting
Bharatpur, Nepal, 44207
Contact: Shankar Laudari    (977) 9845112909    lshankar2@hotmail.com   
Chitwan Medical College Recruiting
Bharatpur, Nepal
Contact: Sudhir Regmi    9855061766      
Nobel medical college and teaching hospital pvt ltd Recruiting
Biratnagar, Nepal, 56613
Contact: Rajesh Nepal    9779851072735    rajesh328@hotmail.com   
Gautam Buddha Community Heart Hospital Recruiting
Butwal, Nepal, 32907
Contact: Samir Gautam    (977) 9852047041    samirgautam22@gmail.com   
BP Koirala Institute of Health Sciences Recruiting
Dharan, Nepal, 56700
Contact: Sanjib Kumar Sharma    (977) 9852047228    drsanjib@yahoo.com   
Manmohan Cardiothoracic Vascular and Trasplant Center, IOM, TU Recruiting
Kathmandu, Nepal, 44600
Contact: Bhagawan Koirala    97714418822    koiralabhagawan@gmail.com   
Sahid Gangalal Heart Center Recruiting
Kathmandu, Nepal, 44600
Contact: Chandra Mani Adhikari    977-9851212111    topjhap@gmail.com   
Bheri Zonal Hospital Recruiting
Nepalgunj, Nepal, 21900
Contact: Krishna Adhikari    9779846163520    kpadhi01@yahoo.com   
Manipal College of Medical Sciences Recruiting
Pokhara, Nepal, 33700
Contact: Navaraj Paudel    (977) 85685037    drnavarajmd@gmail.com   
Nigeria
Federal Medical Center Recruiting
Abeokuta, Nigeria
Contact: Taiwo Olunuga    2348034084681    taiwoolunuga@yahoo.com   
University of Nigeria Teaching Hospital Active, not recruiting
Enugu, Nigeria, 400201
College of Medicine, University of Ibadan Recruiting
Ibadan, Nigeria, 200212
Contact: Abiodun Moshood Adeoye    2348072000017    adeoyemoshood@yahoo.com   
Jos University Teaching Hospital Recruiting
Jos, Nigeria, 930001
Contact: Fidelia Bode-Thomas    234-8033298152    bodefide@yahoo.com   
Ahmadu Bello University Teaching Hospital Recruiting
Kaduna, Nigeria, 810001
Contact: Muhammad Sani Isa    2348058885818    smuhdisa87@gmail.com   
Aminu Kano University Teaching Hospital Recruiting
Kano, Nigeria, 700223
Contact: Mahmoud Umar Sani    2348033479179    sanimahmoud@yahoo.com   
Department of Medicine, Lagos University Teaching Hospital Not yet recruiting
Lagos, Nigeria, 12003
Contact: Amam Mbakwem    2308023033675    ambakwem@hotmail.com   
Ladoke Akintola University of Technology Teaching Hospital Recruiting
Ogbomoso, Nigeria, 4007
Contact: Adeseye Akintunde    2348033932076    iakintunde2@yahoo.com   
Department of Medicine, Delta State University Teaching Hospital Not yet recruiting
Oghara, Nigeria
Contact: E.M Umuerri    2348033487741    umuerriejiro@gmail.com   
Olabisi Onabanjo University Teaching Hospital Not yet recruiting
Sagamu, Nigeria, 234
Contact: Oluranti Familoni    2348023371725    drrantifamiloni@yahoo.com   
Pakistan
Punjab Institute of Cardiology Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Abdul Khan Faisal    0322804484    drwajidkhan@hotmail.com   
Contact: Sidra Sarwar    0322804484      
Isra University Hospital Recruiting
Hyderabad, Pakistan, 31300
Contact: Feroz Memon    92 22 2030161    fsmemon@hotmail.com   
Nishtar Hospital Multan Recruiting
Multan, Pakistan, 60000
Contact: Abubakr A\ Ali Saad    3006301326    cardiocon18@gmail.com   
Lady Reading Hospital Recruiting
Peshawar, Pakistan, PK 2500
Contact: Mohammed Hafizullah    3018588888    vc@kmu.edu.pk   
Rawalpindi Institute of Cardiology Recruiting
Rawalpindi, Pakistan, 46000
Contact: Azhar Mahmood Kayani    923008545949    azharkayani@gmail.com   
Paraguay
Instituto Nacional de Cardiología Recruiting
Asunción, Paraguay, 1725
Contact: Cesar Delmas    595 971 204139      
Contact: cedeba58@gmail.com         
Hospital Barrio Obrero Recruiting
Asunción, Paraguay, 2279
Contact: Gladys de Atobe         
Contact    595 21 372989 / 595-961603164    glangelica3@gmail.com   
Hospital Regional de Ciudad Del Este Recruiting
Ciudad del Este, Paraguay, 7000
Contact: Luciano Pereira    595-61-506710    eleper@gmail.com   
Hospital Nacional Itaugua Recruiting
Itaugua, Paraguay, 2740
Contact: Luz Cabral Gueyraud    595981820956    luzcabral@yahoo.com   
Clinical Hospital Recruiting
San Lorenzo, Paraguay, 1863
Contact: Javier Galeano    595 981 552393      
Contact    595 981 552393    nancygomezali@yahoo.com.ar   
Philippines
Palawan Medical City Recruiting
Puerto Princesa City, Palawan, Philippines, 5300
Contact: Josefina Cruz    63 919 6907025    wengcruz@yahoo.com   
Philippine General Hospital Recruiting
Manila, Philippines, 1000
Contact: Antonio Dans    639175390929    antoniodans@gmail.com   
Philippine Heart Center Recruiting
Quezon City, Philippines, 1100
Contact: Maria Teresa B. Abola    6329296373    tesabola@mac.com   
Quirino Memorial Medical Center Recruiting
Quezon City, Philippines, 1109
Contact: Dennis Jose Sulit    63-917-811-8844    dsulit@vasia.com   
Rwanda
University of Rwanda, Kigali University Teaching Hospital Recruiting
Kigali, Rwanda
Contact: Emmanuel Kamanzi Rusingiza    250785466254    erkamanzi@gmail.com   
South Africa
Nelson Mandela Academic Hospital Recruiting
Mthatha, Eastern Cape, South Africa, 5099
Contact: Baby Mookenthottathil Thomas    27 82 200 7777    mookenthomas@gmail.com   
Charlotte Maxeke Academic Hospital Recruiting
Johannesburg, Parktown, South Africa, 2193
Contact: Pravin Manga    0871503659    ntmoeti@witshealth.co.za   
Sefako Makgatho Health Sciences University Recruiting
Ga-Rankuwa,, Pretoria, South Africa, 0204
Contact: Pindile Mntla    083 676 6933    Pindile.Mntla@smu.ac.za   
Cardiology Research Universitas private hospital Recruiting
Bloemfontein, South Africa, 9301
Contact: Makoali Makotoko    27515063655    makotokoem@ufs.ac.za   
University of Cape Town Recruiting
Cape Town, South Africa, 7925
Contact: Liesl Zuhike, MD    0027768444074    liesl.zuhlke@uct.ac.za   
Contact: Veronica Francis       veronica.francis@uct.ac.za   
Margate Clinical Trial Center Not yet recruiting
Margate, South Africa, 4275
Contact: Dr. Panajatovic    27393127385    panajatovic@gmail.com   
University of Limpopo Recruiting
Polokwane, South Africa, 700
Contact: Andrew Rampule Ratsela    015 287 5416    mavivo@icon.co.za   
Port Elizabeth Hospital Complex Recruiting
Port Elizabeth, South Africa, 6001
Contact: Lungile Pepeta    827766024    Dr.L.Pepeta@gmail.com   
Chris Hani Baragwanath Hospital Recruiting
Soweto, South Africa, 2013
Contact: Richard Nethononda    837120094    Mashudu.Nethononda@wits.ac.za   
Sudan
Alobeid Teaching Hospital Active, not recruiting
Alobeid, Sudan
Atbara Teaching Hospital Active, not recruiting
Atbara, Sudan
Ahmed Gasim Hospital Active, not recruiting
Khartoum, Sudan, 1111
Alshaab Teaching Hospital Active, not recruiting
Khartoum, Sudan, 1111
Ahmed Gasim Pediatric Hospital Active, not recruiting
Khartoum, Sudan
Sudan Heart Center Recruiting
Khartoum, Sudan
Contact: Magdi Gameel Yousif    24991232236    magdigameel@hotmail.com   
Digna Prince Hospital Active, not recruiting
Port Sudan, Sudan
Medani Heart Centre Active, not recruiting
Wad Medani, Sudan
Tanzania
Muhimbili University of Health and Allied Sciences Recruiting
Dar es Salaam, Tanzania
Contact: Pilly Chillo    255 713 779781    pchillo2000@yahoo.co.uk   
University of Dodoma Teaching Hospital Recruiting
Dodoma, Tanzania, 255
Contact: John Meda    686464999    jmedaus@yahoo.com   
Mbeya Zonal Referral Hospital Recruiting
Mbeya, Tanzania, 419
Contact: Issakwisa Mwakyula    255787381388    ozzanne@gmail.com   
Uganda
Uganda Heart Institute Recruiting
Kampala, Uganda
Contact: Emmy Okello    256775522284    emmyoks@gmail.com   
Zambia
Livingstone Central Hospital Active, not recruiting
Livingstone, Zambia, 10101
University Teaching Hospital (UTH) Active, not recruiting
Lusaka, Zambia
Ndola Central Hospital Active, not recruiting
Ndola, Zambia, 10101
Zimbabwe
Mpilo Hospital, National University Science & Technology Recruiting
Bulawayo, Zimbabwe
Contact: Mark Dixon    263 9 61632    mark.dixon@me.com   
Harare Hospital Recruiting
Harare, Zimbabwe
Contact: Noleen Munyandu-Mbuwayesango    263772225489    jhakim@mweb.co.zw   
Parirenyatwa Hospital Recruiting
Harare, Zimbabwe
Contact: James Hakim    263772225489    jhakim@mweb.co.zw   
Sponsors and Collaborators
Population Health Research Institute
University of Cape Town
Bayer
Investigators
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Principal Investigator: Stuart Connolly, MD Population Health Research Institute

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02832544     History of Changes
Other Study ID Numbers: INVICTUS - VKA
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: cumulative participant data only
Keywords provided by Population Health Research Institute:
atrial fibrillation
stroke
Additional relevant MeSH terms:
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Rheumatic Heart Disease
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Aspirin
Vitamins
Vitamin K
Rivaroxaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors