Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease
2015年9月28日 更新者：First Affiliated Hospital of Harbin Medical University
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS).
Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation.
However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs.
In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively.
But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients.
A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects.
This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients.
In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients.
Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.
調査の概要
詳細な説明
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS).
Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation.
However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs.
In addition, a growing body of data supported that East Asian might have different adverse event profiles (thrombophilia and bleeding) and "therapeutic window" compared with white subjects.
Furthermore, "East Asian paradox" phenomenon has been also described that East Asian patients have a higher prevalence of platelet reactivity during DAPT, but an ischaemic event rate following percutaneous coronary intervention (PCI) or ACS is similar or even lower than white patients.
In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively.
But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients.
A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects.
This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients.
In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients.
Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.
研究の種類
介入
入学 (予想される)
30
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92101-92117
- 募集
- VerifyNow
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コンタクト：
- Meijiao He, Master
- 電話番号：518-393-2200
- メール：customerservice@accriva.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Stable Coronary Artery Disease
- stable angina
- low-risk unstable angina
- variant angina
- patients with asymptomatic with appropriate therapy（including percutaneous coronary intervention）.
Exclusion Criteria:
- ACS
- planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period
- platelet count <100g/L
- creatinine clearance rate < 30ml/min
- diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction < 40%)
- a history of bleeding tendency
- aspirin, ticagrelor or clopidogrel allergies
- diabetes.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：クロピドグレル
低用量のチカグレロルと従来の用量のクロピドグレルの安全性と有効性の違いを観察する。
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low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
他の名前：
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
他の名前：
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実験的：low-dose ticagrelor
To observe the safety and efficacy of low-dose ticagrelor in Chinese patients withStable Coronary Artery Disease
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low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
他の名前：
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
他の名前：
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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 |
|---|---|
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P2Y12 reaction units (PRU)
時間枠：up to 5 months
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up to 5 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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inhibition of platelet aggregation (IPA)
時間枠：up to 5 months
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up to 5 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Yue Li, MD、Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年7月1日
一次修了 (予想される)
2015年10月1日
研究の完了 (予想される)
2015年11月1日
試験登録日
最初に提出
2015年7月21日
QC基準を満たした最初の提出物
2015年8月3日
最初の投稿 (見積もり)
2015年8月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年9月30日
QC基準を満たした最後の更新が送信されました
2015年9月28日
最終確認日
2015年7月1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。