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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
Lothian
-
Edinburgh、Lothian、英国、EH16 4SA
- Edinburgh Heart Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:18F-F Positive - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
|
oral, 90mg tablets, twice daily, 12 month duration
其他名称:
|
安慰剂比较:18F-F Positive - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
|
Oral tablet (identical to ticagrelor), twice daily, 12 month duration
|
实验性的:18F-F Negative - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
|
oral, 90mg tablets, twice daily, 12 month duration
其他名称:
|
安慰剂比较:18F-F Negative - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
|
Oral tablet (identical to ticagrelor), twice daily, 12 month duration
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake.
大体时间:30 days
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Plasma hsTnI concentrations in patients without coronary 18F-fluoride uptake.
大体时间:30 days
|
30 days
|
|
High sensitivity cardiac troponin I (hsTnI) concentration in total study population.
大体时间:30 days
|
30 days
|
|
Plasma high-sensitivity troponin (hsTnI) concentration
大体时间:1 year
|
In total population and in 18F-F PET positive and negative sub-groups
|
1 year
|
Calcium score and plaque volume at the site of baseline coronary 18F-fluoride uptake
大体时间:1 year
|
1 year
|
合作者和调查者
合作者
调查人员
- 学习椅:David E. Newby, PhD、University of Edinburgh
- 首席研究员:Philip D. Adamson, MBChB、University of Edinburgh
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.