The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study (SYMPTOMS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02379806|
Recruitment Status : Recruiting
First Posted : March 5, 2015
Last Update Posted : April 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Enoxaparin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5030 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Active enoxaparin 40 mg
One 0.4 ml prefilled syringe containing 40 mg enoxaparin active substance administered once daily for 10 ± 4 days
Other Name: Lovenox
Placebo Comparator: Placebo of enoxaparin 40 mg
One 0.4 ml placebo syringe of enoxaparin 40 mg administered once daily for 10 ± 4 days
- Composite 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 ]
- Composite 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. [ Time Frame: Occurence of any of the events through the Day 30 and Day 90 visit ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379806
|Contact: Dominique MOTTIER, PU-PH||+33 2 98 34 73 email@example.com|
Show 54 Study Locations