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Anticoagulant

Heparin for Community-Acquired Pneumonia (ATTACC-CAP Trial)

Phase 3
Recruiting
Led By Ryan Zarychanski, MD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by radiographic evidence of new or worsening infiltrate and one or more of the following signs and/or symptoms of lower respiratory tract infection
Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 90 days, and 180 days
Awards & highlights

ATTACC-CAP Trial Summary

This trial will compare the effects of heparin to usual care on outcomes for people admitted to hospital with pneumonia.

Who is the study for?
Adults hospitalized with community-acquired pneumonia (CAP) needing oxygen, expected to stay at least 72 hours post-randomization. They must have a primary diagnosis of CAP with new or worsening lung infiltrates and symptoms of lower respiratory infection. Excluded are those admitted over 72 hours, on chronic ventilation, not using thromboprophylaxis, needing full anticoagulation for other reasons, suspected COVID-19, in ICU on life support measures at enrollment time, or with bleeding risks.Check my eligibility
What is being tested?
The trial is testing if therapeutic-dose heparin improves outcomes compared to standard care in hospitalized patients with CAP. It's an international study where participants are randomly assigned to receive either heparin or usual care and the results will be evaluated adaptively as they come in.See study design
What are the potential side effects?
Heparin can cause bleeding problems including bruising easily and prolonged bleeding from cuts. Some may experience allergic reactions like rashes or itching. Rarely it can lead to a drop in platelets causing clotting issues known as HIT (heparin-induced thrombocytopenia).

ATTACC-CAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the hospital with pneumonia confirmed by a lung scan and symptoms.
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I need extra oxygen to help me breathe.
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I expect to stay in the hospital for at least 3 days after being assigned to a study group.
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I am 18 years old or older.

ATTACC-CAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 90 days, and 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 90 days, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ordinal endpoint reflecting survival
Secondary outcome measures
All cause mortality
Bleeding events
HIT events
+4 more

Side effects data

From 2008 Phase 4 trial • 541 Patients • NCT00277394
9%
Urinary tract infection
8%
Haematoma
6%
Constipation
4%
Pain in extremity
4%
Diarrhoea
2%
Deep vein thrombosis
2%
Cardiac failure
1%
International normalised ratio increased
1%
Melaena
1%
Subcutaneous haematoma
1%
Coagulation time prolonged
1%
Left ventricular failure
1%
Multi-organ failure
1%
Fall
1%
Sudden death
1%
Death
1%
General physical health deterioration
1%
Lung neoplasm malignant
1%
Metastatic neoplasm
1%
Respiratory failure
1%
Pulmonary embolism
1%
Depression
1%
Anaemia
1%
Rectal haemorrhage
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Innohep®
Heparin

ATTACC-CAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic-Dose HeparinExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heparin
2003
Completed Phase 4
~22600

Find a Location

Who is running the clinical trial?

Canadian Critical Care Trials GroupOTHER
30 Previous Clinical Trials
224,285 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,449,514 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
4,238,504 Patients Enrolled for Community-acquired Pneumonia
Ozmosis Research Inc.Industry Sponsor
20 Previous Clinical Trials
1,015 Total Patients Enrolled

Media Library

Heparin (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT05848713 — Phase 3
Community-acquired Pneumonia Research Study Groups: Usual Care, Therapeutic-Dose Heparin
Community-acquired Pneumonia Clinical Trial 2023: Heparin Highlights & Side Effects. Trial Name: NCT05848713 — Phase 3
Heparin (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848713 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA endorsed Therapeutic-Dose Heparin?

"Our team at Power has evaluated the safety of therapeutic-dose heparin with a score of 3; this is due to its Phase 3 status and accumulation of evidence supporting both efficacy and safety."

Answered by AI

Are there any spaces available to join this clinical research?

"Clinicaltrials.gov reports that this medical trial, which was first posted on May 1st 2023 and most recently updated April 28th 2023 is not currently accepting applications. However, there are 190 other investigations actively enrolling patients at this time."

Answered by AI

To what extent is this experiment currently being implemented in medical centers?

"Particularly, Ochsner Clinic in Jefferson, Louisiana; Maine Medical Centre in Portland, Maine and Dearborn Michigan are trialing this medication. Moreover, there are 34 additional sites."

Answered by AI

Who else is applying?

What site did they apply to?
Vancouver General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
2023. "AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05848713.
~2667 spots leftby Mar 2028
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