AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

NCT05848713 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ATTACC-CAPOZM-129
• Study Type: interventional
• Target: 4,000
• Locations: 3 countries
• Sites: 64

Brief Summary

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Conditions

Community-acquired Pneumonia

Keywords

Pneumonia; Heparin; Anticoagulation; Community acquired pneumonia; Unfractionated Heparin; Low Molecular Weight Heparin; Dalteparin; Enoxaparin; Tinzaparin

Outcome Measures

Primary Outcomes (1)

• Ordinal endpoint reflecting survival

  Survival to hospital discharge without ICU-level organ support. Organ support is defined as receipt of high flow nasal oxygen, invasive or non-invasive mechanical ventilation, vasopressor/inotropic therapy, or extracorporeal life support (ECLS) within an ICU. This outcome reflects disease progression to ICU-level organ failure or the worst possible outcome (death). It was chosen because of its importance to patients, clinicians, and other stakeholders. Given the limited number of ICU beds, reducing the burden of critical illness has important health system capacity implications.

  30 days

Secondary Outcomes (8)

• Bleeding events

  14 days

• HIT events

  14 days

• Thrombotic events

  30 days and 90 days

• Invasive mechanical ventilation

  30 days

• All cause mortality

  30 days, 90 days, and 180 days

Study Arms (2)

Therapeutic-Dose Heparin

EXPERIMENTAL

Participants randomized to the investigational arm will receive a pragmatic strategy of therapeutic-dose low molecular-weight heparin (LMWH) or unfractionated heparin (UFH) administered daily for up to 14 days or until hospital discharge, whichever occurs first. Participants should start receiving study drug as soon as possible following randomization.

Drug: Heparin

Usual Care

NO INTERVENTION

Participants randomized to the control arm will receive usual care thromboprophylactic dose anticoagulation according to local practice. To ensure adequate separation between the study groups, the dose of heparin/LMWH used in the usual care arm should not equal more than half of the approved therapeutic dose for that agent according to local VTE treatment protocols.

Interventions

Heparin DRUG

Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient. Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.

Therapeutic-Dose Heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age
• Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by:
• Radiographic evidence of new or worsening infiltrate
• One or more of the following signs and/or symptoms of lower respiratory tract infection
• i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician
• Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
• Hospital admission anticipated to last ≥72 hours from randomization

You may not qualify if:

• Suspected or confirmed active COVID-19 infection
• Hospital admission for \>72 hours prior to randomization
• Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment
• Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
• Patients for whom the intent is to not use pharmacologic thromboprophylaxis
• Patients with an independent indication for therapeutic-dose anticoagulation
• Patients with a contraindication to therapeutic-dose anticoagulation, including:
• Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission
• History of an inherited or acquired bleeding disorder
• Cerebral aneurysm or mass lesions of the central nervous system
• Ischemic stroke within 3 months of hospital admission
• Gastrointestinal bleeding within 3 months of hospital admission
• Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening
• Other physician-perceived contraindications to therapeutic anticoagulation
• History of heparin induced thrombocytopenia (HIT) or other heparin allergy

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Research Manitoba: collaborator
• Ozmosis Research Inc.: collaborator
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator
• Canadian Critical Care Trials Group: collaborator
• Avanti PC: collaborator
• Aurora Clinical Research: collaborator

Study Sites (64)

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Ochsner Clinic

Jefferson, Louisiana, 70121, United States

RECRUITING

Maine Medical Centre

Portland, Maine, 04102, United States

RECRUITING

Henry Ford Health System

Dearborn, Michigan, 48128, United States

COMPLETED

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Estadual Dr. Jayme Santos Neves

Serra, Espírito Santo, 29166-828, Brazil

RECRUITING

Hospital Evangelico de Vila Velha

Vila Velha, Espírito Santo, Brazil

RECRUITING

Hospital Universitário Cassiano Antonio Moraes

Vitória, Espírito Santo, Brazil

NOT YET RECRUITING

Santa Casa de Misericordia de Itabuna

Itabuna, Estado de Bahia, Brazil

COMPLETED

Hospital Brasilia

Brasília, Federal District, Brazil

COMPLETED

Hospital Sao Brasilia

Brasília, Federal District, Brazil

NOT YET RECRUITING

Instituto de Cardiologia e Transplantes do Distrito Federal

Brasília, Federal District, Brazil

RECRUITING

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Goiânia, Goiás, Brazil

RECRUITING

Hospital Ruy Azeredo

Goiânia, Goiás, Brazil

RECRUITING

Instituto Goiano de Oncologia e Hematologia - INGOH

Goiânia, Goiás, Brazil

RECRUITING

Hospital Felicio Rocho

Belo Horizonte, Minas Gerais, Brazil

RECRUITING

NUPEC-Orizonti

Belo Horizonte, Minas Gerais, Brazil

COMPLETED

Hospital do Rocio

Campo Largo, Paraná, 83606-177, Brazil

RECRUITING

Hospital Santa Cruz

Curitiba, Paraná, Brazil

RECRUITING

PUCPR

Curitiba, Paraná, Brazil

COMPLETED

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

RECRUITING

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Hospital Universitario de Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

RECRUITING

Hospital Sao Jose

Criciúma, Santa Catarina, Brazil

RECRUITING

Hospital Regional Homero Miranda Gomes

São José, South Carolina, Brazil

COMPLETED

Hospital de Reabilitacao de Anomalias Craniofaciais

Bauru, São Paulo, Brazil

NOT YET RECRUITING

UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

RECRUITING

Hospital Universitario Sao Francisco na Providencia na Deus

Bragança Paulista, São Paulo, Brazil

RECRUITING

Fundação Centro Médico de Campinas

Campinas, São Paulo, 13083-190, Brazil

RECRUITING

IPECC

Campinas, São Paulo, Brazil

RECRUITING

CiTen - Centro Hospital Municipal Antonio Giglio

Osasco, São Paulo, Brazil

RECRUITING

Hospital Regional de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

RECRUITING

Hospital Estadual de Serrana

Ribeirão Preto, São Paulo, Brazil

NOT YET RECRUITING

Hospital Nipo-Brasileiro

São Paulo, São Paulo, 02189-010, Brazil

RECRUITING

HCFMUSP

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

NOT YET RECRUITING

Santa Casa de Misericordia de Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Grand Prairie Regional Hospital

Grande Prairie, Alberta, T8V 4B1, Canada

NOT YET RECRUITING

Nanaimo Regional General Hospital

Nanaimo, British Columbia, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Health Sciences Center Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Grace General Hospital

Winnipeg, Manitoba, Canada

RECRUITING

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

RECRUITING

Memorial University

St. John's, Newfoundland and Labrador, A1C 5S7, Canada

RECRUITING

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 2H3, Canada

RECRUITING

Hamilton Health Sciences - Juravinski

Hamilton, Ontario, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

Markham Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

RECRUITING

Hôpital Montfort

Ottawa, Ontario, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Niagara Health System - St Catharines Site

Saint Catherines, Ontario, L2S 0A9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G2C4, Canada

NOT YET RECRUITING

Centre Hospitalier de Quebec - Hotel-Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

RECRUITING

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

CHU de Quebec-University Laval

Québec, Quebec, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

RECRUITING

Related Publications (1)

• ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler PR, Goligher EC, Berger JS, Neal MD, McVerry BJ, Nicolau JC, Gong MN, Carrier M, Rosenson RS, Reynolds HR, Turgeon AF, Escobedo J, Huang DT, Bradbury CA, Houston BL, Kornblith LZ, Kumar A, Kahn SR, Cushman M, McQuilten Z, Slutsky AS, Kim KS, Gordon AC, Kirwan BA, Brooks MM, Higgins AM, Lewis RJ, Lorenzi E, Berry SM, Berry LR, Aday AW, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Costantini TW, de Brouwer S, Derde LPG, Detry MA, Duggal A, Dzavik V, Effron MB, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Galanaud JP, Galen BT, Gandotra S, Garcia-Madrona S, Girard TD, Godoy LC, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Hamburg NM, Haniffa R, Hanna G, Hanna N, Hegde SM, Hendrickson CM, Hite RD, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Hudock K, Hunt BJ, Husain M, Hyzy RC, Iyer VN, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski AL, King AJ, Knudson MM, Kornblith AE, Krishnan V, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Lima FG, Linstrum K, Litton E, Lopez-Sendon J, Lopez-Sendon Moreno JL, Lother SA, Malhotra S, Marcos M, Saud Marinez A, Marshall JC, Marten N, Matthay MA, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Moore SC, Morillo Guerrero R, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nunez-Garcia B, Pandey A, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Perez Gonzalez YS, Pompilio M, Prekker ME, Quigley JG, Rost NS, Rowan K, Santos FO, Santos M, Olombrada Santos M, Satterwhite L, Saunders CT, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Shankar-Hari M, Sheehan JP, Singhal AB, Solvason D, Stanworth SJ, Tritschler T, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Wells BJ, Widmer RJ, Wilson JG, Yuriditsky E, Zampieri FG, Angus DC, McArthur CJ, Webb SA, Farkouh ME, Hochman JS, Zarychanski R. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. Epub 2021 Aug 4.

  PMID: 34351721 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

Heparin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Ryan Zarychanski, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Patrick Lawler, MD

  University Health Network and McGill University

  PRINCIPAL INVESTIGATOR

• Sylvain Lother, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Alexis Turgeon, MD

  L'Universite Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantale Pineau

CONTACT

2042353223; attacc.cap@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adaptive stratified randomized clinical trial with Bayesian stopping rules

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 8, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CA (25); BR (33); US (6)