Ticagrelor vs Clopidogrel Effect on MFR in CAD Population (PATH)
ComPArison of the Effect of Ticagrelor Versus Clopidogrel on Myocardial Blood Flow (MBF) and Reserve (MBFR) Measured With Positron Emission TomograpHy (PET) in Patients With Coronary Artery Disease (CAD): The PATH Study
Ticagrelor is one of 3 anti-platelet medications used in patients with acute coronary syndrome (ACS) to prevent further clot formation and further ischemic damage to myocardial tissue. Overall benefits of one drug over the other is neutral in this generally unstable population. In pre-clinical trials, ticagrelor showed secondary effects, involving the release of adenosine to heart muscle where the demand for blood was increased due to a stress condition. Blood flow was increased, potentially preventing potential damage.
This study will compare ticagrelor, currently only approved for use in ACS patients, against clopidogrel by measuring the myocardial blood flow(MBF) during stress to validate this phenomenon. The effect on blood flow will be measurable by using two specific doses of adenosine as the pharmacologic stress and correlating with measurements of blood flow using positron emission tomography (PET) nuclear imaging.
This study hypothesizes that the increase in MBF during intermediate dose adenosine infusion will be greater in ticagrelor treated subjects compared to clopidogrel treated subjects
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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-
Ontario
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Ottawa、Ontario、カナダ、K1Y 4W7
- University of Ottawa Heart Institute
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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
説明
Inclusion Criteria:
- Age ≥ 18 years old
- Stable coronary artery disease on stable medical treatment.
- BMI equal to or less than 30 kg/m2
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant arrhythmias on baseline 12-lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 7 days following the end of dosing treatment.
Exclusion Criteria:
- Any contraindication against the use of clopidogrel, ticagrelor and/or ASA.
- Oral anticoagulation therapy.
- History of intracranial bleeding.
- Recent or active pathological bleeding, such as peptic ulcer.
- Moderate or severe hepatic impairment.
- History or risk of bradycardia.
- Known second- or third-degree AV block without pacemaker
- Dyspnea (NYHA III/IV), wheezing asthma or COPD.
- Coronary artery bypass graft (CABG) surgery within 90 days prior to screening or at any time after consent.
- Percutaneous coronary intervention (PCI) within 90 days prior to screening or at any time following consent.
- Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent.
- Any scheduled surgery during the trial period, including dental.
- Concomitant therapy with strong cytochrome CYP 3A inhibitor or inducer.
- Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
- Known hypersensitivity to the investigational drug or any of its components.
- Known hypersensitivity to adenosine.
- Lactose intolerance
- Breastfeeding or pregnancy.
- Claustrophobia or inability to lie still in a supine position
- Unwillingness to provide informed consent
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:クロスオーバー割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:stable CAD management
Experimental: Ticagrelor (BrilintaTM) 90 mg tablet by mouth twice a day
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Blinded administration of ticagrelor for 10 days
他の名前:
Blinded administration of clopidogrel and placebo for 10 days
|
|
アクティブコンパレータ:CAD comparison group
Active comparator: clopidogrel 75 mg plus placebo tablet by mouth twice a day.
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Blinded administration of ticagrelor for 10 days
他の名前:
Blinded administration of clopidogrel and placebo for 10 days
|
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 |
|---|---|---|
|
Differences in rest MBF, stress MBF and MBFR between ticagrelor and clopidogrel treated patients as measured by PET
時間枠:q 2 weeks blood flow measurements
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Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure MBF. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effect will not be known until the study has completed and the treatment unblinded. |
q 2 weeks blood flow measurements
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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 |
|---|---|---|
|
The effect of ticagrelor on rest MBF, stress MBF and MBFR will be compared in the normal versus abnormal segments on a segmental and patient basis in the ticagrelor treated subjects
時間枠:q 2 weeks blood flow measurements
|
Blinded study drug will be administered for 10 days after which the subject will undergo MPI imaging to measure rest/stress MBF and myocardial blood flow reserve. The crossover to the other study arm will occur and the study procedure repeated. Actual study drug effecting flow will not be known until the study has completed and the treatment unblinded. |
q 2 weeks blood flow measurements
|
協力者と研究者
捜査官
- 主任研究者:Terrence Ruddy, MD、Ottawa Heart Institute Research Corporation
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20130105-01H
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