DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury (DIAMOND)
Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients With Necrotic High-Risk Coronary Plaque Disease
Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall of heart blood vessels. It appears that this process can also frequently occur without causing any symptoms and these events likely explain the development of narrowing within the heart arteries which can subsequently produce symptoms of angina (chest pain).
Previous research has shown a specialised scanner known as a PET (positron emission tomography) scan can identify these recently ruptured plaques in patients without symptoms of a heart attack and these patients have changes on a blood test (troponin) which suggest that they are at higher risk of having a heart attack in the future. This study aims to identify these patients using the PET scan and then see if the markers of increased heart attack risk can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well recognised treatment for people who have suffered a recent heart attack.
調査の概要
詳細な説明
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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Lothian
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Edinburgh、Lothian、イギリス、EH16 4SA
- Edinburgh Heart Centre
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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:
- Patients aged ≥40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
- Provision of informed consent prior to any study specific procedures
Exclusion Criteria:
- An acute coronary syndrome within the last 12 months
- An indication for dual anti-platelet therapy, such as drug eluting stent
- Inability to take aspirin
- Receiving thienopyridine therapy such as clopidogrel or prasugrel
- Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
- Inability or unwilling to give informed consent
- Woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
- Known hypersensitivity to ticagrelor or one of its excipients
- Active pathological bleeding or bleeding diathesis
- Significant thrombocytopenia: <100 x 10^9 /L
- History of intracranial haemorrhage
- Moderate to severe liver impairment (Child's Grade B or C)
- Maintenance therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
- Major intercurrent illness or life expectancy <1 year
- Renal dysfunction (eGFR ≤30 mL/min/1.73 m2)
- Contraindication to iodinated contrast agents
- Planned coronary revascularization or major non-cardiac surgery in the next 12 months
- Maintenance therapy with simvastatin at doses greater than 40mg daily
- Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:18F-F Positive - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
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oral, 90mg tablets, twice daily, 12 month duration
他の名前:
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プラセボコンパレーター:18F-F Positive - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
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Oral tablet (identical to ticagrelor), twice daily, 12 month duration
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実験的:18F-F Negative - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
|
oral, 90mg tablets, twice daily, 12 month duration
他の名前:
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プラセボコンパレーター:18F-F Negative - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
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Oral tablet (identical to ticagrelor), twice daily, 12 month duration
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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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Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake.
時間枠:30 days
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30 days
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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 |
---|---|---|
Plasma hsTnI concentrations in patients without coronary 18F-fluoride uptake.
時間枠:30 days
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30 days
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High sensitivity cardiac troponin I (hsTnI) concentration in total study population.
時間枠:30 days
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30 days
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Plasma high-sensitivity troponin (hsTnI) concentration
時間枠:1 year
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In total population and in 18F-F PET positive and negative sub-groups
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1 year
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Calcium score and plaque volume at the site of baseline coronary 18F-fluoride uptake
時間枠:1 year
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1 year
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協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア:David E. Newby, PhD、University of Edinburgh
- 主任研究者:Philip D. Adamson, MBChB、University of Edinburgh
出版物と役立つリンク
一般刊行物
- Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
- Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.
- Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Moss AJ, Doris MK, Andrews JPM, Bing R, Daghem M, van Beek EJR, Forsyth L, Shah ASV, Williams MC, Sellers S, Leipsic J, Dweck MR, Parker RA, Newby DE, Adamson PD. Molecular Coronary Plaque Imaging Using 18F-Fluoride. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008574. doi: 10.1161/CIRCIMAGING.118.008574. Epub 2019 Aug 6.
- Doris MK, Meah MN, Moss AJ, Andrews JPM, Bing R, Gillen R, Weir N, Syed M, Daghem M, Shah A, Williams MC, van Beek EJR, Forsyth L, Dey D, Slomka PJ, Dweck MR, Newby DE, Adamson PD. Coronary 18F-Fluoride Uptake and Progression of Coronary Artery Calcification. Circ Cardiovasc Imaging. 2020 Dec;13(12):e011438. doi: 10.1161/CIRCIMAGING.120.011438. Epub 2020 Dec 10.
- Moss AJ, Dweck MR, Doris MK, Andrews JPM, Bing R, Forsythe RO, Cartlidge TR, Pawade TA, Daghem M, Raftis JB, Williams MC, van Beek EJR, Forsyth L, Lewis SC, Lee RJ, Shah ASV, Mills NL, Newby DE, Adamson PD. Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque. JACC Cardiovasc Imaging. 2020 Jul;13(7):1549-1560. doi: 10.1016/j.jcmg.2019.05.023. Epub 2019 Aug 14.
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
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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Ticagrelorの臨床試験
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Collegium Medicum w Bydgoszczyまだ募集していません
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University Hospital, Toulouse完了