Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality
Ключови думи
Резюме
Описание
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.
The efficacity of the cardiovascular active prevention will be studied by comparing the rate of Event free Survival between patients in the Experimental Arm Versus usual Clinical practices
The duration of participation for a subject is equal to 2 years
Дати
| Последна проверка: | 11/30/2019 |
| Първо изпратено: | 11/14/2018 |
| Очаквано записване подадено: | 11/14/2018 |
| Първо публикувано: | 11/18/2018 |
| Изпратена последна актуализация: | 12/19/2019 |
| Последна актуализация публикувана: | 12/22/2019 |
| Действителна начална дата на проучването: | 12/19/2019 |
| Приблизителна дата на първично завършване: | 11/30/2021 |
| Очаквана дата на завършване на проучването: | 11/30/2023 |
Състояние или заболяване
Интервенция / лечение
Combination Product: active prevention
Combination Product: usual clinical practice
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: active prevention optimal medical treatment | Combination Product: active prevention Life style modifications, Monitoring of the risk factors and Optimal medical treatment Lipid-lowering treatment, anti-platelet treatment and ACEi or AT2 antagonists treatment for a total duration of 24 months |
| Sham Comparator: usual clinical practice usual clinical practice in each center | Combination Product: usual clinical practice usual clinical practice in each center |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Adults over 18 years - CML "Philadelphia chromosome" in chronic phase treated with nilotinib or ponatinib for, in first or second line - Written informed consent must be obtained prior to protocol-specific procedures - Affiliation to a social security category Exclusion Criteria: - Revascularization already decided and scheduled - Life threatening disease - Recent history of myocardial infarction or stroke - Unstable angina - Hypotension (Blood pressure < 90/50mmHg) - Pregnancy and lactation - Women of childbearing potential not using appropriate contraceptive measures - Contraindication for statin - Contraindication for aspirin - Contraindication for ACEi or AT2 antagonists treatment - Known hypersensitivity to rosuvastatin or fluvastatin, other ingredients in the product - Known hypersensitivity to aspirin, other ingredients in the product, other salicylates or non-steroidal anti-inflammatory drugs - Known hypersensitivity to ACEi or AT2 antagonists treatment, other ingredients in the product - Hereditary or idiopathic angioedema ; or history of angioedema - Hyperaldosteronism - Active liver disease, or unexplained, persistent elevations in serum transaminases - Severe renal impairment (creatinine clearance <30 ml/min) - Myopathy - Concomitant cyclosporine treatment - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - Severe heart failure - Concurrent severe diseases which exclude the administration of therapy - Patients under reinforced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research - Absence of affiliation to a social security agency - Inability to understand the instructions or objectives of the study - Absence of signed informed consent |
Резултат
Първични изходни мерки
1. Improvementof the Event Free Survival (EFS) rate in CML patients with an active and systematic prevention for cardiovascular risk. [24 months]
