Working… Menu

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. Identifier: NCT02832544
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : April 26, 2019
University of Cape Town
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

Layout table for study information
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.

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

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 identifier (NCT number): NCT02832544

Layout table for location contacts
Contact: Gayle D Lewis 1-866-414-7474
Contact: Sumathy Rangarajan, MSc 1-866-414-7474

  Hide Study Locations
Layout table for location information
Princess Marina Hospital Recruiting
Gaborone, Botswana
Contact: Onkabetse Julia Molefe-Baikai    267-72492039 / 267-3621400   
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   
Instituto de Pesquisa Clínica de Campinas Recruiting
Campinas, Brazil, 13060-080
Contact: José Francisco Kerr Saraiva    19 9 96015550   
LOEMA - Instituto de Pesquisa Clínica & Consultores Ltda Recruiting
Campinas, Brazil, São Paulo
Contact: Fabio Rossi dos Santos    +55 19 998096000   
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   
Instituto Dante Pazzanese de Cardiologia Recruiting
São Paulo, Brazil, 4012909
Contact: Auristela Ramos    55-11-996296961   
Santa Casa de Misericórdia de Votuporanga Recruiting
Votuporanga, Brazil, 15500-003
Contact: Mauro Hernandes    5517991459465   
Clinique Coeur Et Vie Recruiting
Douala, Cameroon, 7562
Contact: DJOMOU NGONGANG FLORENT ARMEL    237651117187   
Douala General Hospital Recruiting
Douala, Cameroon
Contact: Anastase Dzudie    237 679617981   
St. Elizabeth Catholic General Hospital, Cardiac Centre Recruiting
Kumbo, Cameroon
Contact: Tantchou Tchoumi Jacques Cabral    237 699323742   
Hopital Central Yaounde Recruiting
Yaounde, Cameroon
Contact: Ntep Gweth Ngo Youmba    699668692   
China, Beijing
Liangxiang Hospital Recruiting
Beijing, Beijing, China, 102401
Contact: Yu Qing    13911551534   
China, Guangdong
The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University Recruiting
Guangzhou, Guangdong, China, 510062
Contact: Wei Zhang    13610330852   
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   
Tieli People's Hospital Recruiting
Yichun, Heilongjiang, China, 152500
Contact: Niu Yanbo    13134587500   
China, Henan
Luoyang Central's Hospital Affiliated to Zhengzhou University Recruiting
Luoyang, Henan, China, 471009
Contact: Zhang Shouyan    13938801812   
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   
Suiping Renan Hospital Recruiting
Zhumadian, Henan, China, 463100
Contact: Sun Jinpo    13839941874   
China, Hubei
Jianshi County People's Hospital Recruiting
Enshi, Hubei, China, 445308
Contact: Ma Mingfu    13997795565   
China, Jiangsu
Suqian Peaple's Hospital of Nanjing Drum-Tower Hospital Group Recruiting
Suqian, Jiangsu, China, 223800
Contact: Hao Ding    18012186826   
China, Jilin
Tonghua Central Hospital Recruiting
Tonghua, Jilin, China, 134001
Contact: Wang Shudong    13944592198   
China, Liaoning
Affiliated Zhongshan Hospital of Dalian University Recruiting
Dalian, Liaoning, China, 116001
Contact: Wang Xiaomei    1 359 1384353   
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   
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   
Anyue County People's Hospital Recruiting
Ziyang, Sichuan, China, 642350
Contact: Xu Yongbin    13708260302   
China, Wendeng
Wendeng Central Hospital Recruiting
Weihai, Wendeng, China
Contact: Jinguo Zhao    135 6185 2177   
China, Zhejiang
Ninghai People's Hospital Recruiting
Ningbo, Zhejiang, China, 315600
Contact: Wang Xiaoying    15906562636   
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Contact: Ma Changsheng    13901357404   
Zhongmou County People's Hospital Recruiting
Henan, China, 450000
Contact: Kong Xiuzhen    13663851005   
Zhengzhou No.7 People's Hospital Recruiting
Henan, China, 450016
Contact: Yuan Yiqiang    13838125038   
The 1st Affiliated Hospital of Zhengzhou University Withdrawn
Henan, China, 450052
Zhengzhou 9th People's Hospital Recruiting
Henan, China, 450053
Contact: Zhao Mingzhong    15038360018   
Guangshan County People's Hospital Recruiting
Henan, China
Contact: Wang Qi    18537682099   
Wuhan No. 1 Hospital Not yet recruiting
Wuhan, China, 430022
Contact: Liqun He    137 2021 0083   
Alexandria University Hospital Recruiting
Alexandria, Egypt, 21561
Contact: Aly Ahmed Abu Al Huda    002-01226604971   
Assuit General Hospital Recruiting
Assuit, Egypt
Contact: Khalid Mohamed Eltamawey    002-01002867610   
Benha University Cardiology Department Recruiting
Banha, Egypt
Contact: Osama Sanad    1223316682   
Beni Suef University Hospital Active, not recruiting
Beni Suef, Egypt
Ain Shams University Hospital Recruiting
Cairo, Egypt, 11566
Contact: Sameh Shahine    02-224024111   
Kasr El Einy Hospital (Cairo University) Recruiting
Cairo, Egypt, 21561
Contact: Sulaiman Gharib    01006002668   
Mehallah Rheumatic Heart Center Recruiting
El Mahalla El Kubra, Egypt, 31951
Contact: Alaa Elghamrawi    1001834994   
Specialized Medical Hospital - Mansoura Recruiting
El Mansura, Egypt, 35516
Contact: Mahmoud Youssif    002-01005290606   
Fayoum General Hospital Recruiting
Fayoum, Egypt, 31951
Contact: Ramadan Ahmed    1067773573   
National Heart Institute Not yet recruiting
Giza, Egypt, 31951
Contact: Mohamed Helmi    02-233025022   
Suez Canal University Hospital Recruiting
Ismailia, Egypt, 41522
Contact: Omar Mohamed Saleh    002-01006777612   
El Minia University Hospital Recruiting
Minya, Egypt, 61519
Contact: El Alaa Ibrahim    20114381172200201222196084   
Sohag University, Sohag Recruiting
Sohag, Egypt, 35516
Contact: Aly Mahmood Kassem    093-4600526   
Red Crescent Hospital Active, not recruiting
Tanta, Egypt, 31951
Zagazig University Hospital Active, not recruiting
Zagazig, Egypt, 44519
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
Dr. Ram Manohar Lohia Hospital @ PGIMER Recruiting
New Delhi, Delhi, India, 110001
Contact: Ranjit Nath    9971138171   
Govind Ballabh Pant Hospital (GIPMER) Recruiting
New Delhi, Delhi, India, 110002
Contact: Mohit Gupta    91-9871062464   
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: G. Karthikeyan    91-9871074832   
Sri Jayadev Institute of Cardiovascular Sciences and Research Recruiting
Bangalore, Karnataka, India, 560069
Contact: C. N. Manjunath    919663554483   
SMS Medical College Not yet recruiting
Jaipur, Rajasthan, India, 302004
Contact: Chandra Bhan Meena    9414250934   
King George's Medical College Recruiting
Lucknow, Uttar Pradesh, India, 226003
Contact: Rishi Sethi    9415085717   
Sanjay Gandhi Post Graduate Institute of Medical Sciences Recruiting
Lucknow, Uttar Pradesh, India, 226014
Contact: Sudeep Kumar    91-9919002761   
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Parag Barwad    91-8968732470   
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) Not yet recruiting
Pondicherry, India, 605006
Contact: Santhosh Satheesh    9443426244   
Kazakh National Medical Institute, Not yet recruiting
Almaty, Kazakhstan
Contact: Kairat Davletov    772723301037705625 1730   
Moi Teaching and Referral Hospital Recruiting
Eldoret, Kenya, 30100
Contact: Ayub Felix Barasa    254 723 174 268   
Karen Hospital Recruiting
Nairobi, Kenya, 00200
Contact: Anthony Gikonyo    700535280   
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   
Clinical Hospital of administrative department of President and Government of Kyrgyz Republic Not yet recruiting
Bishkek, Kyrgyzstan, 720001
Contact: Gulmira Baitova    996 550 796883   
National Center of Cardiology and Internal Diseases Not yet recruiting
Bishkek, Kyrgyzstan, 720040
Contact: Nazgul Omurzakova    996-556-555911   
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi, 265
Contact: Tamara Phiri         
Kumuzu Central Hospital Recruiting
Lilongwe, Malawi, 265
Contact: Lillian Gondwe-Chunda    265997614090   
Mzuzu Central Hospital Recruiting
Mzuzu, Malawi, 265
Contact: Frank Sinyiza    265885554425   
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   
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   
Instituto Nacional de Cardiología Ignacio Chavez Active, not recruiting
México, Mexico, 14080
Maputo Central Hospital Recruiting
Maputo, Mozambique, 1111
Contact: Albertino Damasceno    258 823061160   
Instituto Nacional de Saude & Universidade Eduardo Mondlane Recruiting
Maputo, Mozambique, CP 264
Contact: Ana Mocumbi    258 82 3294990   
College of Medical Sciences Recruiting
Bharatpur, Nepal, 44207
Contact: Shankar Laudari    (977) 9845112909   
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   
Gautam Buddha Community Heart Hospital Recruiting
Butwal, Nepal, 32907
Contact: Samir Gautam    (977) 9852047041   
BP Koirala Institute of Health Sciences Recruiting
Dharan, Nepal, 56700
Contact: Sanjib Kumar Sharma    (977) 9852047228   
Manmohan Cardiothoracic Vascular and Trasplant Center, IOM, TU Recruiting
Kathmandu, Nepal, 44600
Contact: Bhagawan Koirala    97714418822   
Sahid Gangalal Heart Center Recruiting
Kathmandu, Nepal, 44600
Contact: Chandra Mani Adhikari    977-9851212111   
Bheri Zonal Hospital Recruiting
Nepalgunj, Nepal, 21900
Contact: Krishna Adhikari    9779846163520   
Manipal College of Medical Sciences Recruiting
Pokhara, Nepal, 33700
Contact: Navaraj Paudel    (977) 85685037   
Federal Medical Center Recruiting
Abeokuta, Nigeria
Contact: Taiwo Olunuga    2348034084681   
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   
Jos University Teaching Hospital Recruiting
Jos, Nigeria, 930001
Contact: Fidelia Bode-Thomas    234-8033298152   
Ahmadu Bello University Teaching Hospital Recruiting
Kaduna, Nigeria, 810001
Contact: Muhammad Sani Isa    2348058885818   
Aminu Kano University Teaching Hospital Recruiting
Kano, Nigeria, 700223
Contact: Mahmoud Umar Sani    2348033479179   
Department of Medicine, Lagos University Teaching Hospital Not yet recruiting
Lagos, Nigeria, 12003
Contact: Amam Mbakwem    2308023033675   
Ladoke Akintola University of Technology Teaching Hospital Recruiting
Ogbomoso, Nigeria, 4007
Contact: Adeseye Akintunde    2348033932076   
Department of Medicine, Delta State University Teaching Hospital Not yet recruiting
Oghara, Nigeria
Contact: E.M Umuerri    2348033487741   
Olabisi Onabanjo University Teaching Hospital Not yet recruiting
Sagamu, Nigeria, 234
Contact: Oluranti Familoni    2348023371725   
Punjab Institute of Cardiology Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Abdul Khan Faisal    0322804484   
Contact: Sidra Sarwar    0322804484      
Isra University Hospital Recruiting
Hyderabad, Pakistan, 31300
Contact: Feroz Memon    92 22 2030161   
Nishtar Hospital Multan Recruiting
Multan, Pakistan, 60000
Contact: Abubakr A\ Ali Saad    3006301326   
Lady Reading Hospital Recruiting
Peshawar, Pakistan, PK 2500
Contact: Mohammed Hafizullah    3018588888   
Rawalpindi Institute of Cardiology Recruiting
Rawalpindi, Pakistan, 46000
Contact: Azhar Mahmood Kayani    923008545949   
Instituto Nacional de Cardiología Recruiting
Asunción, Paraguay, 1725
Contact: Cesar Delmas    595 971 204139      
Hospital Barrio Obrero Recruiting
Asunción, Paraguay, 2279
Contact: Gladys de Atobe         
Contact    595 21 372989 / 595-961603164   
Hospital Regional de Ciudad Del Este Recruiting
Ciudad del Este, Paraguay, 7000
Contact: Luciano Pereira    595-61-506710   
Hospital Nacional Itaugua Recruiting
Itaugua, Paraguay, 2740
Contact: Luz Cabral Gueyraud    595981820956   
Clinical Hospital Recruiting
San Lorenzo, Paraguay, 1863
Contact: Javier Galeano    595 981 552393      
Contact    595 981 552393   
Palawan Medical City Recruiting
Puerto Princesa City, Palawan, Philippines, 5300
Contact: Josefina Cruz    63 919 6907025   
Philippine General Hospital Recruiting
Manila, Philippines, 1000
Contact: Antonio Dans    639175390929   
Philippine Heart Center Recruiting
Quezon City, Philippines, 1100
Contact: Maria Teresa B. Abola    6329296373   
Quirino Memorial Medical Center Recruiting
Quezon City, Philippines, 1109
Contact: Dennis Jose Sulit    63-917-811-8844   
University of Rwanda, Kigali University Teaching Hospital Recruiting
Kigali, Rwanda
Contact: Emmanuel Kamanzi Rusingiza    250785466254   
South Africa
Nelson Mandela Academic Hospital Recruiting
Mthatha, Eastern Cape, South Africa, 5099
Contact: Baby Mookenthottathil Thomas    27 82 200 7777   
Charlotte Maxeke Academic Hospital Recruiting
Johannesburg, Parktown, South Africa, 2193
Contact: Pravin Manga    0871503659   
Sefako Makgatho Health Sciences University Recruiting
Ga-Rankuwa,, Pretoria, South Africa, 0204
Contact: Pindile Mntla    083 676 6933   
Cardiology Research Universitas private hospital Recruiting
Bloemfontein, South Africa, 9301
Contact: Makoali Makotoko    27515063655   
University of Cape Town Recruiting
Cape Town, South Africa, 7925
Contact: Liesl Zuhike, MD    0027768444074   
Contact: Veronica Francis   
Margate Clinical Trial Center Not yet recruiting
Margate, South Africa, 4275
Contact: Dr. Panajatovic    27393127385   
University of Limpopo Recruiting
Polokwane, South Africa, 700
Contact: Andrew Rampule Ratsela    015 287 5416   
Port Elizabeth Hospital Complex Recruiting
Port Elizabeth, South Africa, 6001
Contact: Lungile Pepeta    827766024   
Chris Hani Baragwanath Hospital Recruiting
Soweto, South Africa, 2013
Contact: Richard Nethononda    837120094   
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   
Digna Prince Hospital Active, not recruiting
Port Sudan, Sudan
Medani Heart Centre Active, not recruiting
Wad Medani, Sudan
Muhimbili University of Health and Allied Sciences Recruiting
Dar es Salaam, Tanzania
Contact: Pilly Chillo    255 713 779781   
University of Dodoma Teaching Hospital Recruiting
Dodoma, Tanzania, 255
Contact: John Meda    686464999   
Mbeya Zonal Referral Hospital Recruiting
Mbeya, Tanzania, 419
Contact: Issakwisa Mwakyula    255787381388   
Uganda Heart Institute Recruiting
Kampala, Uganda
Contact: Emmy Okello    256775522284   
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
Mpilo Hospital, National University Science & Technology Recruiting
Bulawayo, Zimbabwe
Contact: Mark Dixon    263 9 61632   
Harare Hospital Recruiting
Harare, Zimbabwe
Contact: Noleen Munyandu-Mbuwayesango    263772225489   
Parirenyatwa Hospital Recruiting
Harare, Zimbabwe
Contact: James Hakim    263772225489   
Sponsors and Collaborators
Population Health Research Institute
University of Cape Town
Layout table for investigator information
Principal Investigator: Stuart Connolly, MD Population Health Research Institute

Layout table for additonal information
Responsible Party: Population Health Research Institute 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
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Heart Disease
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamin K
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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