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Venous ThromboembolismPhase 3SYMPTOMSNCT02379806

The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study

A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by University Hospital, Brest at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Enoxaparin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,560 participants
Where
46 sitesin 2 countries
Study dates
3 Sep 2015to 29 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient aged 70 years or older
  • Admitted to hospital for an acute medical illness
  • Anticipated duration of hospitalization of at least 4 days
  • Life expectancy of at least 3 months

Who cannot join

  • Admission for one of the following reasons:
  • Planned medical procedure.
  • Routine health assessment requiring admission for baseline/trending of health status (e.g., routine colonoscopy).
  • Admission encountered for another life circumstance that causes no bearing on health status and requires no medical intervention (e.g., lack of housing, economic inadequacy, care-giver respite, family circumstances, administrative).
  • Hypersensitivity to heparin
  • History of Heparin Induced Thrombocytopenia
Show all 17Show fewer
  • Active bleeding
  • Bacterial endocarditis
  • Platelet count of less than 80,000 per cubic millimeter
  • Patients who require anticoagulant therapy for any indication, and those who received any type of anticoagulant therapy for > 48 hours
  • Organic lesion prone to bleeding.
  • Hemorrhagic events or bleeding tendency due to hemostasis disorders.
  • Concomitant use of aspirin (> 160 mg/day), clopidogrel (> 75 mg/day), or of combined antiplatelet therapy
  • Creatinine clearance < 15 ml/min
  • Unable or unwilling to consent
  • Ischemic stroke + hemorrhagic transformation
  • Patient requiring admission to Intensive Care Unit

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

France45 sites

  • Centre Hospitalier d'Agen

    Agen, 47000

  • CHU Angers

    Angers, 49000

  • CH Angoulême

    Angoulême, 16959

  • CH d'Arras

    Arras, 62022

  • CH Béthune

    Béthune, 62400

  • Hôpital Jean Verdier (APHP)

    Bondy, 93143

  • CHU Bordeaux

    Bordeaux, 33075

  • HIA Clermont-Tonnerre

    Brest, 29200

  • CHRU Brest

    Brest, 29609

  • CH Public du Cotentin

    Cherbourg, 50102

  • CH Louis Mourier de Colombes

    Colombes, 97200

  • CHU de Dijon

    Dijon, 21000

  • CHU Grenoble

    Grenoble, 38700

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Groupe Hospitalier Le Havre

    Le Havre

  • CHU Rouen

    Le Petit-Quevilly, 76140

  • CHRU de Lille

    Lille, 59000

  • CHU Limoges

    Limoges, 87042

  • CHD Vendée - Site de Luçon

    Luçon, 85400

  • Hôpital Edouard Herriot - CHU Lyon

    Lyon, 69003

  • CHU Lyon

    Lyon, 69495

  • Hôpital de la Timone - AP-HM

    Marseille, 13274

  • Clinique Mutualiste Médico-chirurgical "Beau Soleil"

    Montpellier

  • CH des Pays de Morlaix

    Morlaix, 29600

  • CHU Nancy

    Nancy, 54035

  • CHU de Nantes

    Nantes, 44000

  • Hôpital Cimiez - CHU Nice

    Nice, 03003

  • HEGP - Paris

    Paris, 75000

  • Hôpital Lariboisiere

    Paris, 75000

  • Hôpital Saint-Antoine (APHP)

    Paris, 75012

  • Hôpital Broca- APHP

    Paris, 75013

  • Hôpita Cochin - APHP

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • CH Périgueux

    Périgueux, 24019

  • CHU Poitiers

    Poitiers, 86021

  • CH de Cornouaille - Quimper

    Quimper, 29107

  • CHU Rennes

    Rennes, 35203

  • Hôpital Charles Nicolle- CHU Rouen

    Rouen, 76230

  • CHU La Réunion - Site Félix Guyon

    Saint-Denis, 97411

  • CHU de Saint Etienne

    Saint-Etienne, 42000

  • CHU La Réunion - site du GHSR

    Saint-Pierre, 97410

  • CHRU Strasbourg- Service HTA et Maladies Vasculaires

    Strasbourg, 67091

  • CHU Strasbourg - Service de Médecine Interne

    Strasbourg, 67091

  • CH Intercommunal Toulon La Seyne sur Mer

    Toulon, 83056

  • HIA Sainte-Anne Toulon

    Toulon, 83800

Other trials in France

Switzerland1 site

  • Hôpitaux Universitaires de Genève

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients Aged 70 Years and Older : a Randomized Placebo-Controlled Study The SYMPTOMS (SYstematic Elderly Medical Patients Thromboprophylaxis : Efficacy on Symptomatic OutcoMeS) Study

Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden.

The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.

Read more

Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.

However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.

Being tested
Enoxaparin, Placebo
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02379806
Study groupRoleWhat they receive
Active enoxaparin 40 mgActive comparatorOne 0.4 ml prefilled syringe containing 40 mg enoxaparin active substance administered once daily for 10 ± 4 days
Receives: Drug: Enoxaparin
Placebo of enoxaparin 40 mgPlacebo comparatorOne 0.4 ml placebo syringe of enoxaparin 40 mg administered once daily for 10 ± 4 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of the following events: symptomatic confirmed deep venous thrombosis (DVT), symptomatic confirmed pulmonary embolism (PE), or fatal PE

    Measured: Occurence of any of the events through the Day 30 visit

Secondary outcomes (1)

  1. Occurence of the following events: Major bleeding, clinically relevant non major bleeding, symptomatic confirmed VTE (DVT or PE) or fatal PE, atherothrombotic cardiovascular events, cardiovascular death, Death from any cause.

    The secondary outcomes is the occurrence of any of the following events:

    • Major bleeding as defined by the criteria of the International Society of Thrombosis and Haemostasis at day 30 and day 90
    • Clinically relevant non major bleeding and any bleeding at day 30 and day 90
    • Symptomatic confirmed VTE (DVT or PE) or fatal PE through the day 90 visit
    • Atherothrombotic cardiovascular events at day 30 and day 90
    • Cardiovascular death at day 30 and day 90
    • Death from any cause at day 30 and day 90
    • Rate of VTE and bleeding events at day 30 and day 90 according to creatinin clearance (< 50 ml/min and ≥ 50 ml/min), age range, D-dimer level and the use or not of antiplatelet therapy to identified the population at risk for VTE and bleeding.

    Measured: Occurence of any of the events through the Day 30 and Day 90 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study start3 Sep 2015
  3. Primary completionDec 2020
  4. Study completion29 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,560 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379806
Sponsor's protocol ID
29BRC14.0012 SYMPTOMS
Other IDs
2014-000311-13, 2014
Acronym
SYMPTOMS
Status last verified
Jun 2022
First submitted
16 Feb 2015
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Mottier D, Girard P, Couturaud F, Lacut K, Le Moigne E, Paleiron N, Guellec D, Sanchez O, Cogulet V, Laporte S, Marhic G, Mismetti P, Presles E, Robert-Ebadi H, Mahe I, Plaisance L, Reny JL, Darbellay Farhoumand P, Cuvelier C, Le Henaff C, Lambert Y, Danguy des Deserts M, Rousseau Legrand C, Boutreux S, Bleher Y, Decours R, Trinh-Duc A, Armengol G, Benhamou Y, Daumas A, Guyot SL, De Carvalho H, Lamia B, Righini M, Meyer G, Le Gal G. Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients. NEJM Evid. 2023 Aug;2(8):EVIDoa2200332. doi: 10.1056/EVIDoa2200332. Epub 2023 Jun 27.

    PubMed 38320142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by University Hospital, Brest at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of the following events: symptomatic confirmed deep venous thrombosis (DVT), symptomatic confirmed pulmonary embolism (PE), or fatal PE (time frame: Occurence of any of the events through the Day 30 visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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