Determinants of Oral Anticoagulants' Activity (ANTIGOAG)
Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.
The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.
Results will lead to a better prediction of both drug response and risk of complications.
調査の概要
詳細な説明
Direct oral anticoagulants are changing clinical practices but a better knowledge of factors that may predict both drug response and risk of complications is need.
Anticoagulant activity is influenced by different factors. Because the biological activity is not easy to measure everywhere, it is important to clearly determine factors that are involved.
A cohort of 550 patients that receive either an anti-IIa or an anti-Xa will be recruited.
The primary objective is to determine clinical, biological and genetic determinants of anticoagulant activity.
This objective will be assessed through a multivariate logistic regression (separately for anti-IIa and anti-Xa) with anticoagulant activity as dependent variable.
Variables that will be included in the statistical model are those known or measured at the entry in the cohort such as :
- Clinical factors : age, sex, weight, dosage and time of the last dose
- Biological factors : serum creatinine level, plasma concentration of the drug
- Genetic polymorphisms :
Factor II and CES1 for anti-IIa drugs Factor X, CYP3, CYP3A4, CYP3A5 and ABCG2 for anti-Xa drugs.
By using the same statistical approach and the same variables, predictive factors of either hemorrhagic or thrombotic events will also be evaluated on the whole cohort. The occurence of hemorrhagic and thrombotic complications will then be assessed through a phone call every 3 months during a one-year follow-up.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Lille、フランス、59037
- University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patient receiving direct oral anticoagulant
- Complete blood count and measure of hemostasis planned
- Patient able to give consent
- Patient with health insurance
Exclusion Criteria:
- Patient not able to consent
- Patient under 18 years old
- Patient refusal
- Patient without health insurance
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Anti-IIa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti IIa anticoagulant including analysis of PK-PD genetic polymorphisms
|
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
|
|
Anti-Xa users
Determination of predictors of anticoagulant activity in a prospective cohort of patients using oral anti Xa anticoagulant including analysis of PK-PD genetic polymorphisms
|
PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurement of anticoagulant activity level
時間枠：Baseline
|
Multivariate analysis to determine clinical, biological or genetic predictors of anticoagulant activity level as measured by anti-IIa or anti-Xa activity
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Occurence of any hemorrhagic complication
時間枠：One year follow-up
|
Multivariate analysis to determine clinical, biological or genetic predictors of hemorrhagic complications under direct oral anticoagulant
|
One year follow-up
|
|
Occurence of any thrombotic complication
時間枠：One year follow-up
|
Multivariate analysis to determine clinical, biological or genetic predictors of thrombotic complications under direct oral anticoagulant
|
One year follow-up
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2014_26
- 2015-A01596-43 (その他の識別子：ID-RCB number, ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
PK-PD genetic polymorphismsの臨床試験
-
Mikkel Krogh-MadsenRigshospitalet, Denmark; Herlev Hospital完了
-
AZ Sint-Jan AVPaul Tulkens, Louvain drug research institute, belgium; Francoise Van Bambeke, Louvain drug... と他の協力者完了
-
Seoul National University Hospitalまだ募集していません
-
Centre Hospitalier Universitaire de Saint Etienne完了
-
Duke UniversityMedical University of South Carolina; Eunice Kennedy Shriver National Institute of Child Health... と他の協力者募集
-
Pierluigi PorcuMillennium Pharmaceuticals, Inc.; Celgene Corporation完了末梢性T細胞リンパ腫 | 未分化大細胞型リンパ腫 | 血管免疫芽球性T細胞リンパ腫 | 成人鼻型節外性NK/T細胞リンパ腫 | 肝脾T細胞リンパ腫 | 移植後リンパ増殖性疾患 | 再発成人T細胞白血病/リンパ腫 | 再発皮膚T細胞非ホジキンリンパ腫 | 再発性菌状息肉腫/セザリー症候群 | 小腸リンパ腫 | 前リンパ性白血病 | T細胞大顆粒リンパ球白血病アメリカ