E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute phase of deep vein thrombosis |
phase aiguë de la thrombose |
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E.1.1.1 | Medical condition in easily understood language |
acute phase of deep vein thrombosis |
phase aiguë de la thrombose |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to illustrate the I-CAM serum levels decrease after an acute DVT |
Mesurer la décroissance des taux sériques de I-CAM en cas de TVP des membres inférieurs |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the relationship between inflammatory markers and clinical symptoms. - To evaluate the relationship between inflammatory markers and the number of patients with partial recanalization (50%) or complete recanalization at 21 days.
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- Évaluer la relation entre marqueurs inflammatoires et symptômes cliniques. - Évaluer la relation entre marqueurs inflammatoires et recanalisation veineuse totale ou partielle à 21 jours après une TVP.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patients with a first episode of symptomatic, proximal DVT of the lower limbs, confirmed by Duplex Ultrasound (DUS) - Indication for treatment with Tinzaparin
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- Patient de 18 ans ou plus présentant une thrombose veineuse profonde aigue des membres inférieurs diagnostiquée par Echographie Doppler. - Candidat à un traitement par Tinzaparine
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E.4 | Principal exclusion criteria |
- Recent DVT (less than 2 months) other than the index event with or without PE - Severe ilio-femoral DVT requiring recanalization - Duration of treatment of more than 24 h since diagnosis - Planned surgery in the following 3 weeks, impossible to postpone - Active haemorrhage or high risk of haemorrhage - Symptoms of Post Thrombotic Syndrome - Active neoplasm - APL syndrome - Renal insufficiency (Creatinine clearance (Cockcroft-Gault) <20 mL/min) -Hepatic disease / or Hepatic Insufficiency / or serious liver disease - Any anti-inflammatory drugs or anti-platelet therapy - Any other concomitant anticoagulant treatment such as VKA, heparin, fondaparinux - Contraindications to LMWH according to their SmPC
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- TVP récente avec ou sans Embolie pulmonaire de moins de 2 mois autre que l’évènement index – -TVP iliofémorale sévère nécessitant une recanalisation -Traitement reçu depuis plus de 24h - Chirurgie prévue dans les 3 semaines suivantes impossible à reporter -Haut risque hémorragique ou hémorragie active - syndrome post thrombotique - cancer actif connu - syndrome des anti-phopholipides - Insuffisance rénale avec clairance de Cockroft inférieure à 20 ml/mn -Insuffisance hépato-cellulaire - Traitement anti-inflammatoire ou anti-plaquettaire ne pouvant être interrompu - traitement anticoagulant autre que celui prescrit - Contre-indication à l’héparine
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E.5 End points |
E.5.1 | Primary end point(s) |
CAM levels variation in each patient during time |
Taux d’I-CAM pour chaque patient au cours du temps |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Levels of other biological inflammation markers during the study (CRP, IL-6, IL-8, IL-10, Pselectin, TFPI, D Dimers, NETS, MMP2, MMP9, VIII, TGT,PPL-ct, C3c, C4c, Xa activity, factor II and IV) - Percentage of complete recanalization measured by duplex ultrasoundat day 21 - Comparison between recanalization and inflammatory markers
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Taux de marqueurs au cours du temps (CRP, IL-6, IL-8, IL-10, Pselectine, TFPI, D Dimeres, NETS, MMP2, MMP9, VIII, TGT, PPL-ct, C3c, C4c, Xa activity, facteur II et IV) - poucentage de recanalization echographique à J21 - comparaison entre recanalization et taux sériques des marqueurs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1, 3,5,7,10,15 and day 21 |
jour 1, 3,5,7,10,15 et jour 21 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |