CRUSHed vs. Uncrushed Prasugrel in STEMI Patients Undergoing PCI (CompareCrush)
COMPARison of Pre-hospital CRUSHed vs. Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
The study is a two-centre, randomized, 1:1 trial comparing prehospital prasugrel initiation therapy between crushed vs. uncrushed prasugrel tablets on efficacy and safety as well as pharmacodynamics in STEMI patients.
Patients with STEMI planned for primary PCI will be screened and, if inclusion criteria are met, included at first medical contact (paramedics). After enrolment, patients will be randomly assigned (1:1) to receive 60mg prasugrel loading dose by ingesting integral or crushed tablets.
The follow-up duration is 12 months, i.e. clinical outcomes will be analysed in-hospital, at 30 days, and 12 months
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Rotterdam、オランダ、3015 CE
- Erasmus Medical Center
-
Rotterdam、オランダ、3079 DZ
- Maasstadziekenhuis
-
-
参加基準
適格基準
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
説明
Inclusion Criteria:
Consecutive patients with STEMI planned for primary PCI:
- Deferred written informed consent within 4 hours after prasugrel loading dose
- Adult men and women aged at least 18 years
- Symptoms of acute MI of more than 30 min but less than 6 hours
- New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads
Exclusion Criteria:
- Contraindication to prasugrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed, history of any CVA including TIA, moderate to severe hepatic impairment, GI bleed within the past 6 months, major surgery within past 4 weeks)
- Patient who has received loading dose of clopidogrel or ticagrelor for the index event or are on chronic treatment of ticagrelor, or prasugrel. However, patients on maintenance dose clopidogrel for at least 7 days are included in the study (see appendix A).
- Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring chronic therapy)
- Planned fibrinolytic treatment
- Patient requiring dialysis
- Known, clinically important thrombocytopenia
- Known clinically important anaemia
- Known pregnancy or lactation
- Need for a concomitant systemic therapy with strong inhibitors or strong inducers of CYP3A
- Condition which may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock with severe hemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up)
- Patient unable to swallow oral medication (i.e. intubated patients)
- Patient who have not received prasugrel loading dose in the ambulance
- Patient who vomited after randomization / receiving the loading dose prasugrel
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ:Uncrushed
6 Integral tablets Prasugrel as loading dose
|
loading dose of 6 integral tablets of 10mg Prasugrel
他の名前:
|
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実験的:Crushed
6 Crushed tablets Prasugrel as loading dose
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loading dose of 6 crushed tablets 10mg Prasugrel
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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Co-primary endpoint is the percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment resolution directly post-PCI
時間枠:directly post PCI
|
To assess the efficacy of crushed vs. integral tablets of prasugrel loading dose treatment by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment elevation resolution directly post-PCI.
|
directly post PCI
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in hospital, at 30 days and 12 months
時間枠:upto 72 hours after randomisation, at 30 days and 12 months.
|
Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during inhospital stay, 30 days and 12 months of study
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upto 72 hours after randomisation, at 30 days and 12 months.
|
|
Composite of death, MI, urgent revascularization during inhospital, at 30 days and 12 months of study
時間枠:30 days and 12 months
|
Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study
|
30 days and 12 months
|
|
Individual endpoints during inhospital, at 30 days and 12 months of study
時間枠:upto 72 hours after randomisation, at 30 days and 12 months.
|
Percentage of patients presenting with any of the individual endpoints during inhospital, 30 days and 12 months of study
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upto 72 hours after randomisation, at 30 days and 12 months.
|
|
Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
時間枠:directly post PCI
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Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
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directly post PCI
|
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Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
時間枠:pre-PCI and 60 min post-PCI
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Complete (≥ 70%) ST-segment elevation resolution pre-PCI and 60 min post-PCI
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pre-PCI and 60 min post-PCI
|
|
Corrected TIMI frame count (cTFC) at angiography, pre and post PCI.
時間枠:pre PCI, directly post PCI
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Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
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pre PCI, directly post PCI
|
|
TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
時間枠:pre PCI, directly post PCI
|
TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI.
|
pre PCI, directly post PCI
|
|
Time-relationship (from symptom onset to 1st dose intake) on each co-primary
時間枠:directly post-PCI
|
Time from symptom onset to 1st dose intake correlated to TIMI flow grade 3 of MI culprit vessel at initial angiography and on ≥70% ST-segment elevation resolution directly post-PCI
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directly post-PCI
|
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Time-relationship (from 1st dose intake to ECG/ angiography) on each co-primary
時間枠:directly post-PCI
|
Time from first dose intake to ECG correlated to ≥70% ST-segment elevation resolution directly post-PCI and time from randomization to initial angiography correlated to TIMI flow grade 3 of MI culprit vessel
|
directly post-PCI
|
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TIMI flow grade 3 at end of procedure.
時間枠:directly post PCI
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TIMI flow grade 3 at end of procedure.
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directly post PCI
|
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Myocardial Blush at the start and end of the procedure
時間枠:pre PCI, directly post PCI
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Myocardial Blush at the start and end of the procedure
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pre PCI, directly post PCI
|
|
Maximum CK, and CK-MB levels
時間枠:upto 72 hours after randomisation
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Maximum CK, and CK-MB levels
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upto 72 hours after randomisation
|
|
Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
時間枠:at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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Level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
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at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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|
Platelet reactivity, at each time point as well as over time
時間枠:at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration
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at time of prasugrel administration, pre PCI, directly post PCI, 4 hours after prasugrel administration
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Rates of HPR
時間枠:upto 72 hours after randomisation
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Percentage of patients with PRU values over HPR threshold
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upto 72 hours after randomisation
|
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Exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine
時間枠:upto 72 hours after randomisation
|
PD of each group among patients stratified for morphine treatment
|
upto 72 hours after randomisation
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:George Vlachojannis, MD, PhD、Maasstadziekenhuis
- スタディディレクター:Pieter C Smits, MD, PhD、Maasstadziekenhuis
- スタディチェア:Nicolas van Mieghem, MD, PhD、Erasmus Medical Center
出版物と役立つリンク
一般刊行物
- Vlachojannis GJ, Wilschut JM, Vogel RF, Lemmert ME, Delewi R, Diletti R, van der Waarden NWPL, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. Effect of Prehospital Crushed Prasugrel Tablets in Patients With ST-Segment-Elevation Myocardial Infarction Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial. Circulation. 2020 Dec 15;142(24):2316-2328. doi: 10.1161/CIRCULATIONAHA.120.051532. Epub 2020 Oct 14.
- Vlachojannis GJ, Vogel RF, Wilschut JM, Lemmert ME, Delewi R, Diletti R, van Vliet R, van der Waarden N, Nuis RJ, Paradies V, Alexopoulos D, Zijlstra F, Montalescot G, Angiolillo DJ, Krucoff MW, Van Mieghem NM, Smits PC. COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions: Rationale and design of the COMPARE CRUSH trial. Am Heart J. 2020 Jun;224:10-16. doi: 10.1016/j.ahj.2020.03.005. Epub 2020 Mar 11.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 2017-40
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
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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。
Prasugrel (Integral tablets)の臨床試験
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NCT06590025募集
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