Full Anticoagulation Versus Prophylaxis in COVID-19: COALIZAO ACTION Trial
ACTION
Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial
1 other identifier
interventional
615
1 country
36
Brief Summary
Pragmatic randomized clinical trial of patients admitted to the hospital with confirmed COVID-19 infection and elevated D-Dimer. Randomization 1:1 - Group 1 will undergo a routine full anticoagulation (oral or parenteral when needed) strategy; and group 2 will receive usual standard of care with prophylactic anticoagulation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2020
Shorter than P25 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
June 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedJune 10, 2021
May 1, 2020
9 months
May 8, 2020
June 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hierarchical composite endpoint composed of mortality, number of days alive, number of days in the hospital and number of days with oxygen therapy at the end of 30 days.
The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner.
In 30 days
Secondary Outcomes (7)
Incidence of Venous thromboembolism
In 30 days
Incidence of acute myocardial infarction
In 30 days
Incidence of stroke
In 30 days
Number of days using oxygen therapy
In 30 days
Peak of troponin
In 30 days
- +2 more secondary outcomes
Study Arms (2)
Group 1
OTHERThe routine full anticoagulation strategy will be applied for 30 days. In this strategy, full anticoagulation therapy will be maintained for all patients randomized to group 1 and, depending on the patient's clinical condition, there will be 2 possible routes of administration (oral or parenteral): * Oral: Rivaroxaban 20 mg 1 x daily (adjust the dose to 15 mg 1x daily if ClCr between 30 and 49ml/min and/or concomitant use of azithromycin); * Parenteral: Enoxaparin 1 mg/kg every 12 hours subcutaneously or Unfractionated heparin (preferable option for patients progressing with disseminated intravascular coagulation).
Group 2
OTHERPatients in this group will receive the usual standard management and currently have no indication of full anticoagulation. Venous thromboembolism (VTE) prophylaxis should be used in group 2 (usual standard of care) as recommended by guidelines.
Interventions
Routine full anticoagulation strategy
Usual standard of care and currently have no indication of full anticoagulation.
Eligibility Criteria
You may qualify if:
- Patients with confirmed diagnosis of COVID-19 admitted to hospital;
- Duration of symptoms related to hospitalization ≤ 14 days;
- Patients ≥ 18 year old;
- D-dimer above the upper limit of normal (collected until 72 hours before the randomization);
- Agreement to participate by providing the informed consent form (ICF).
You may not qualify if:
- Platelets \< 50,000 /mm3
- Need for ASA therapy \> 100 mg;
- Need for P2Y12 inhibitor therapy (clopidogrel, ticagrelor or prasugrel);
- Chronic use of non-hormonal anti-inflammatory drugs;
- Sustained uncontrolled systolic blood pressure (BP) of ≥180 mmHg or diastolic BP of ≥100 mmHg;
- INR \> 1,5;
- Patients contraindicated to full anticoagulation (active bleeding, liver failure, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator);
- Criteria for disseminated intravascular coagulation (DIC);
- A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm;
- Active cancer (excluding non-melanoma skin cancer) defined as cancer not in remission or requiring active chemotherapy or adjunctive therapies such as immunotherapy or radiotherapy;
- Hypersensitivity to rivaroxaban;
- Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort);
- Known HIV infection;
- Creatinine clearance \< 30 ml/min according to the Cockcroft-Gault Formula;
- Pregnancy or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brazilian Clinical Research Institutelead
- Hospital Israelita Albert Einsteincollaborator
- Hospital do Coracaocollaborator
- Hospital Sirio-Libanescollaborator
- Hospital Moinhos de Ventocollaborator
- Hospital Alemão Oswaldo Cruzcollaborator
- Beneficência Portuguesa de São Paulocollaborator
- Brazilian Research In Intensive Care Networkcollaborator
Study Sites (36)
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
Centro de Ensino e Aperfeiçoamento em Pesquisa - CEAP
Serra, Espírito Santo, Brazil
Centro de Estudos Clínicos do Hospital Cárdio Pulmonar
Salvador, Estado de Bahia, Brazil
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil
Centro de Pesquisas Cardiológicas de Goiânia do Hospital das Clínicas (UFG)
Goiânia, Goiás, Brazil
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, Brazil
Núcleo de Ciências de Saúde - Unidade de Pesquisa - Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa Clínica do Hospital de Clínicas da Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, Brazil
Hospital Universitário da Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Hospital Agamenon Magalhães
Recife, Pernambuco, Brazil
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Instituto Baia Sul de Ensino E Pesquisa Dr. Irineu May Brodbeck / Hospital Baía Sul
Florianópolis, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Hospital de Amor de Barretos - (Pio XII)
Barretos, São Paulo, Brazil
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - Unesp
Botucatu, São Paulo, Brazil
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil
Hospital Regional do Litoral Norte
Caraguatatuba, São Paulo, Brazil
Hospital Regional de Registro
Registro, São Paulo, Brazil
Praxis Pesquisa Médica
Santo André, São Paulo, Brazil
Centro Integrado de Pesquisa (CIP) - Hospital de Base de Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Regional de São José dos Campos
São José dos Campos, São Paulo, Brazil
Santa Casa de Misericórdia de Votuporanga
Votuporanga, São Paulo, Brazil
Hospital Naval Marcílio Dias
Rio de Janeiro, Brazil
BP - A Beneficência Portuguesa de São Paulo
São Paulo, Brazil
Hcor - Hospital do Coração
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Hospital Moriah
São Paulo, Brazil
Hospital Samaritano Paulista
São Paulo, Brazil
Hospital Santa Paula
São Paulo, Brazil
Hospital São Paulo
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo
São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP
São Paulo, Brazil
Related Publications (5)
de Barros E Silva PGM, Furtado RHM, de Alcantara Chaud MS, Macedo AVS, Bronhara B, Damiani LP, Barbosa LM, Suiama MA, Ramacciotti E, de Aquino Martins P, de Oliveira AL, Nunes VS, Ritt LEF, Rocha AT, Tramujas L, Santos SV, Diaz DRA, Viana LS, Melro LMG, Figueiredo EL, Neuenschwander FC, Dracoulakis MDA, Lima RGSD, de Souza Dantas VC, Fernandes ACS, Gebara OCE, Hernandes ME, Queiroz DAR, Veiga VC, Canesin MF, de Faria LM, Feitosa-Filho GS, Gazzana MB, Liporace IL, de Oliveira Twardowsky A, Maia LN, Machado FR, de Matos Soeiro A, Conceicao-Souza GE, Armaganijan L, Guimaraes PO, Rosa RG, Azevedo LCP, Alexander JH, Avezum A, Berwanger O, Cavalcanti AB, Lopes RD; ACTION Coalition COVID-19 Brazil IV Investigators. Predictors of bleeding and thrombotic events among patients admitted to the hospital with COVID-19 and elevated D-dimer: insights from the ACTION randomized clinical trial. J Thromb Thrombolysis. 2024 Aug;57(6):1031-1039. doi: 10.1007/s11239-024-02995-y. Epub 2024 May 18.
PMID: 38762708DERIVEDFlumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PMID: 35244208DERIVEDLopes RD, de Barros E Silva PGM, Furtado RHM, Macedo AVS, Bronhara B, Damiani LP, Barbosa LM, de Aveiro Morata J, Ramacciotti E, de Aquino Martins P, de Oliveira AL, Nunes VS, Ritt LEF, Rocha AT, Tramujas L, Santos SV, Diaz DRA, Viana LS, Melro LMG, de Alcantara Chaud MS, Figueiredo EL, Neuenschwander FC, Dracoulakis MDA, Lima RGSD, de Souza Dantas VC, Fernandes ACS, Gebara OCE, Hernandes ME, Queiroz DAR, Veiga VC, Canesin MF, de Faria LM, Feitosa-Filho GS, Gazzana MB, Liporace IL, de Oliveira Twardowsky A, Maia LN, Machado FR, de Matos Soeiro A, Conceicao-Souza GE, Armaganijan L, Guimaraes PO, Rosa RG, Azevedo LCP, Alexander JH, Avezum A, Cavalcanti AB, Berwanger O; ACTION Coalition COVID-19 Brazil IV Investigators. Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial. Lancet. 2021 Jun 12;397(10291):2253-2263. doi: 10.1016/S0140-6736(21)01203-4. Epub 2021 Jun 4.
PMID: 34097856DERIVEDLopes RD, de Barros E Silva PGM, Furtado RHM, Macedo AVS, Ramacciotti E, Damini LP, Bronhara B, Cavalcanti AB, Rosa RG, Azevedo LCP, Veiga VC, Machado FR, Ritt LE, Martins PA, Alexander JH, Avezum A, Berwanger O; Coalition COVID-19 Brazil IV Investigators. Randomized clinical trial to evaluate a routine full anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) admitted to hospital: Rationale and design of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV trial. Am Heart J. 2021 Aug;238:1-11. doi: 10.1016/j.ahj.2021.04.005. Epub 2021 Apr 20.
PMID: 33891907DERIVEDFlumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
PMID: 33502773DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Renato D. Lopes, MD, PhD
BCRI
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 19, 2020
Study Start
June 21, 2020
Primary Completion
March 26, 2021
Study Completion
May 30, 2021
Last Updated
June 10, 2021
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.