Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT)
Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients
調査の概要
詳細な説明
The European Society of Cardiology and American Heart Association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both STEMI and NSTEMI (class of recommendation I, level of evidence B). Recommended dosing regimens of ticagrelor are identical in STEMI and NSTEMI patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. It is not known whether PK and PD features of ticagrelor are uniform in STEMI and NSTEMI patients. However, the existing body of evidence suggest that PK and PD of ticagrelor may be attenuated in STEMI patients compared to healthy subjects and patients with stable coronary artery disease, which may expose STEMI patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. The PINPOINT study could provide a valuable insight into the knowledge regarding ticagrelor action in STEMI vs. NSTEMI patients.
Since there is no reference study comparing pharmacokinetics of ticagrelor in STEMI and NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Kujawsko-pomorskie
-
Bydgoszcz、Kujawsko-pomorskie、ポーランド、85-094
- Cardiology Department, Dr. A. Jurasz 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:
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
- male or non-pregnant female, 18 years old and older
- provision of informed consent for angiography and PCI
Exclusion Criteria:
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
- recent gastrointestinal bleeding (within 30 days)
- history of coagulation disorders
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- second or third degree atrioventricular block during screening for eligibility
- patient required dialysis
- manifest infection or inflammatory state
- Killip class III or IV during screening for eligibility
- respiratory failure
- current therapy with strong CYP3A inhibitors or strong CYP3A inducers
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 |
---|---|
STEMI
ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
|
180 mg loading dose
他の名前:
|
NSTEMI
non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
|
180 mg loading dose
他の名前:
|
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 |
時間枠 |
---|---|
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-6h)
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
|
|
Area under the plasma concentration-time curve for ticagrelor (AUC 0-12h)
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
|
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-12h)
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
|
Maximum concentration (Cmax) of ticagrelor and AR-C124910XX
時間枠:12 hours
|
12 hours
|
|
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
時間枠:12 hours
|
12 hours
|
|
Platelet reactivity index (PRI) assessed by VASP assay
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
|
Platelet reactivity assessed by Multiple Electrode Aggregometry
時間枠:prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors.
|
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
|
Percentage of patients with high platelet reactivity (HPR) after the loading dose of ticagrelor assessed with VASP and Multiple Electrode Aggregometry
時間枠:2 hours
|
2 hours
|
|
Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry
時間枠:12 hours
|
12 hours
|
協力者と研究者
捜査官
- 主任研究者:Jacek Kubica, MD, PhD、Collegium Medicum, Nicolaus Copernicus University
出版物と役立つリンク
一般刊行物
- Adamski P, Sikora J, Laskowska E, Buszko K, Ostrowska M, Uminska JM, Sikora A, Skibinska N, Sobczak P, Adamska U, Rosc D, Kubica A, Paciorek P, Marszall MP, Navarese EP, Gorog DA, Kubica J. Comparison of bioavailability and antiplatelet action of ticagrelor in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction: A prospective, observational, single-centre study. PLoS One. 2017 Oct 12;12(10):e0186013. doi: 10.1371/journal.pone.0186013. eCollection 2017.
- Adamski P, Ostrowska M, Sikora J, Obonska K, Buszko K, Krintus M, Sypniewska G, Marszall MP, Kozinski M, Kubica J. Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT): protocol for a prospective, observational, single-centre study. BMJ Open. 2017 Apr 26;7(4):e013218. doi: 10.1136/bmjopen-2016-013218.
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 (見積もり)
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
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。
ticagrelorの臨床試験
-
Collegium Medicum w Bydgoszczyまだ募集していません
-
University Hospital, Toulouse完了