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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000311-13 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active enoxaparin 40 mg | Active Comparator | One 0.4 ml prefilled syringe containing 40 mg enoxaparin active substance administered once daily for 10 ± 4 days |
|
| Placebo of enoxaparin 40 mg | Placebo Comparator | One 0.4 ml placebo syringe of enoxaparin 40 mg administered once daily for 10 ± 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of the following events: symptomatic confirmed deep venous thrombosis (DVT), symptomatic confirmed pulmonary embolism (PE), or fatal PE | Occurence of any of the events through the Day 30 visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
Admission for one of the following reasons:
Hypersensitivity to heparin
History of Heparin Induced Thrombocytopenia
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Agen | Agen | 47000 | France | |||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38320142 | Derived | 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. |
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| Drug |
|
| Occurence of any of the events through the Day 30 and Day 90 visit |
| Angers |
| 49000 |
| France |
| CH Angoulême | Angoulême | 16959 | France |
| CH d'Arras | Arras | 62022 | France |
| CH Béthune | Béthune | 62400 | France |
| Hôpital Jean Verdier (APHP) | Bondy | 93143 | France |
| CHU Bordeaux | Bordeaux | 33075 | France |
| HIA Clermont-Tonnerre | Brest | 29200 | France |
| CHRU Brest | Brest | 29609 | France |
| CH Public du Cotentin | Cherbourg | 50102 | France |
| CH Louis Mourier de Colombes | Colombes | 97200 | France |
| CHU de Dijon | Dijon | 21000 | France |
| CHU Grenoble | Grenoble | 38700 | France |
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
| Groupe Hospitalier Le Havre | Le Havre | France |
| CHU Rouen | Le Petit-Quevilly | 76140 | France |
| CHRU de Lille | Lille | 59000 | France |
| CHU Limoges | Limoges | 87042 | France |
| CHD Vendée - Site de Luçon | Luçon | 85400 | France |
| Hôpital Edouard Herriot - CHU Lyon | Lyon | 69003 | France |
| CHU Lyon | Lyon | 69495 | France |
| Hôpital de la Timone - AP-HM | Marseille | 13274 | France |
| Clinique Mutualiste Médico-chirurgical "Beau Soleil" | Montpellier | France |
| CH des Pays de Morlaix | Morlaix | 29600 | France |
| CHU Nancy | Nancy | 54035 | France |
| CHU de Nantes | Nantes | 44000 | France |
| Hôpital Cimiez - CHU Nice | Nice | 03003 | France |
| HEGP - Paris | Paris | 75000 | France |
| Hôpital Lariboisiere | Paris | 75000 | France |
| Hôpital Saint-Antoine (APHP) | Paris | 75012 | France |
| Hôpital Broca- APHP | Paris | 75013 | France |
| Hôpita Cochin - APHP | Paris | 75014 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| CH Périgueux | Périgueux | 24019 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| CH de Cornouaille - Quimper | Quimper | 29107 | France |
| CHU Rennes | Rennes | 35203 | France |
| Hôpital Charles Nicolle- CHU Rouen | Rouen | 76230 | France |
| CHU La Réunion - Site Félix Guyon | Saint-Denis | 97411 | France |
| CHU de Saint Etienne | Saint-Etienne | 42000 | France |
| CHU La Réunion - site du GHSR | Saint-Pierre | 97410 | France |
| CHRU Strasbourg- Service HTA et Maladies Vasculaires | Strasbourg | 67091 | France |
| CHU Strasbourg - Service de Médecine Interne | Strasbourg | 67091 | France |
| CH Intercommunal Toulon La Seyne sur Mer | Toulon | 83056 | France |
| HIA Sainte-Anne Toulon | Toulon | 83800 | France |
| Hôpitaux Universitaires de Genève | Geneva | 1211 | Switzerland |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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