Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients (Ticagrelor)
調査の概要
詳細な説明
Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events . However, there is a considerable number of patients who continue to have recurrent ischemic events despite this regimen . In fact, in the last years several clinical factors have been associated with impaired clopidogrel-induced effects. Moreover, these clinical factors are strongly related with the presence of high on-treatment platelet reactivity (HPR), which is also associated with the occurrence of adverse thrombotic events, including stent thrombosis, despite correct treatment compliance. Diabetes mellitus, acute coronary syndromes, obesity or chronic kidney disease (CKD) are common examples . This observation encourages the search for new more potent antiplatelet therapies. A new P2Y12 receptor antagonist, ticagrelor, has been approved for clinical use . Ticagrelor is a new non-thienopyridine, a cyclopentyltriazolo-pyrimidine (CPTP), direct acting reversible P2Y12 antagonist. This compound has a more favorable pharmacokinetic (PK) and pharmacodynamics (PD) profile than clopidogrel , which has translated into better clinical outcomes in patients with acute coronary syndrome (ACS) in a recent large, international clinical trial . Interestingly, ticagrelor has showed an impressive clinical benefit in patients with CKD in comparison with those patients without renal impairment .
CKD is highly associated with an increased risk of atherothrombotic events, including stent thrombosis, in patients with CAD . PD studies have shown that patients with impaired renal function are characterized by reduced clopidogrel-induced antiplatelet effects and higher rates of HPR compared with patients with preserved renal function.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Murcia、スペイン、30120
- 募集
- Hospital Universitario Virgen de La Arrixaca
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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:
- Patients presenting with moderate-high risk non-STEACS defined according the current guidelines
- Patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care
- Age between 18 and 80 years old
- BMI between 18 and 35 kg/m2
- Provide written informed consent prior to any study specific procedures
Exclusion Criteria:
- History of hemorrhagic stroke or intracranial bleeding
- Known allergies to aspirin, ticagrelor, or clopidogrel
- On treatment with oral anticoagulation (Coumarin derivate, dabigatran, rivaroxaban, apixaban)
- Hemoglobin <10 gm/dL
- Platelet count <80x106/mL
- Blood dyscrasias, active bleeding or hemodynamic instability.
- Patients on hemodialysis or peritoneal dialysis, a change in estimated glomerular filtration rate (eGFR) greater than 15 mL/min within 90 days prior to enrollment, or estimated glomerular filtration rate (eGFR) lower than 15 mL/min/1.73m2
- Patients with known infectious diseases or neoplasia
- Baseline ALT >2.5 times the upper limit of normal
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection
- Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid). Since omeprazole is the most used proton-pump inhibitor in our clinical environment, we will keep the same prescription rate in both groups to avoid differences results from this described interaction
- Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin
- Pregnant females
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
- 観測モデル:ケースのみ
- 時間の展望:見込みのある
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 |
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platelet reactivity units
時間枠:7+2 days of treatment
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The primary endpoint is the comparison of the platelet reactivity units (PRU) values determined by VerfifyNow-P2Y12 system between normal renal function and CKD patients after 7±2 days of concomitant treatment with ticagrelor.
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7+2 days of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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platelet reactivity profiles after loading dose of ticagrelor
時間枠:30 min, 1, 2, 4 and 6 hours
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To evaluate platelet reactivity profiles after loading dose of ticagrelor using a 180 mg loading dose at 30 min, 1, 2, 4 and 6 hours, and comparing CKD to non-CKD patients as measured with VerifyNow-P2Y12 system.
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30 min, 1, 2, 4 and 6 hours
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platelet reactivity profiles after 180 mg loading dose to ticagrelor usin MEA
時間枠:30 min, 1, 2, 4 and 6 hours
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To analyze platelet reactivity profiles after 180 mg loading dose to ticagrelor using MEA, at 30 min, 1, 2, 4 and 6 hours and after 90 mg b.i.d maintenance dose of ticagrelor at 7±2 days.
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30 min, 1, 2, 4 and 6 hours
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ticagrelor active metabolite levels
時間枠:30 min, 1, 2, 4 and 6 hours
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To assess ticagrelor active metabolite levels after loading dose of ticagrelor using a 180 mg loading dose at 30 min, 1, 2, 4 and 6 hours, and comparing CKD to non-CKD patients.
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30 min, 1, 2, 4 and 6 hours
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協力者と研究者
捜査官
- 主任研究者:Tello-Montoliu MD Antonio、Hospital Universitario Virgen de La Arrixaca
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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。
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