drugset / Trial / NCT05310968
Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Perforating artery territorial infarction (PAI) refers to a single ischemic lesion in a single perforating arterial territory and branch atheromatous disease (BAD) is an important type. BAD related stroke accounts for 10%-15% ischemic cerebral infarction and is closely related to early neurological deterioration (END). Among patients with single ischemic lesion in other study, dual antiplatelet (clopidogrel plus aspirin) did not significantly reduce the risk of recurrent stroke. The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing the risk of stroke and END in patients with BAD.
Timeline
- Start
- 2022-11-12
- Primary completion
- 2025-02-17
- Completion
- 2025-09-01
Publications
- Background Lu H, Howatt DA, Balakrishnan A, Graham MJ, Mullick AE, Daugherty A. Hypercholesterolemia Induced by a PCSK9 Gain-of-Function Mutation Augments Angiotensin II-Induced Abdominal Aortic Aneurysms in C57BL/6 Mice-Brief Report. Arterioscler Thromb Vasc Biol. 2016 Sep;36(9):1753-7. doi: 10.1161/ATVBAHA.116.307613. Epub 2016 Jul 28.
- Background Seitz RJ, Meisel S, Moll M, Wittsack HJ, Junghans U, Siebler M. The effect of combined thrombolysis with rtPA and tirofiban on ischemic brain lesions. Neurology. 2004 Jun 8;62(11):2110-2. doi: 10.1212/01.wnl.0000129480.17345.4a.
- Background Berberich A, Schneider C, Reiff T, Gumbinger C, Ringleb PA. Dual Antiplatelet Therapy Improves Functional Outcome in Patients With Progressive Lacunar Strokes. Stroke. 2019 Apr;50(4):1007-1009. doi: 10.1161/STROKEAHA.118.023789.
- Background Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. doi: 10.1136/bmj.37991.635266.44. Epub 2004 Jan 26.
- Background Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ. Neuroimaging markers for early neurologic deterioration in single small subcortical infarction. Stroke. 2015 Mar;46(3):687-91. doi: 10.1161/STROKEAHA.114.007466. Epub 2015 Feb 12.
- Background Cohen JE, Rabinstein A, Gomori JM, Leker RR. Capsular warning syndrome and crescendo lacunar strokes after atherosclerotic stenosis of the recurrent artery of Heubner. J Clin Neurosci. 2012 Dec;19(12):1730-3. doi: 10.1016/j.jocn.2012.04.010. Epub 2012 Sep 19.
- Background Del Bene A, Palumbo V, Lamassa M, Saia V, Piccardi B, Inzitari D. Progressive lacunar stroke: review of mechanisms, prognostic features, and putative treatments. Int J Stroke. 2012 Jun;7(4):321-9. doi: 10.1111/j.1747-4949.2012.00789.x. Epub 2012 Mar 30.
- Background Sudlow CL, Warlow CP. Comparable studies of the incidence of stroke and its pathological types: results from an international collaboration. International Stroke Incidence Collaboration. Stroke. 1997 Mar;28(3):491-9. doi: 10.1161/01.str.28.3.491.
- Background Caplan LR. Lacunar infarction and small vessel disease: pathology and pathophysiology. J Stroke. 2015 Jan;17(1):2-6. doi: 10.5853/jos.2015.17.1.2. Epub 2015 Jan 30.
- Background Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31.
- Background Kim BJ, Kim JS. Ischemic stroke subtype classification: an asian viewpoint. J Stroke. 2014 Jan;16(1):8-17. doi: 10.5853/jos.2014.16.1.8. Epub 2014 Jan 31.
- Background Kim JS, Yoon Y. Single subcortical infarction associated with parental arterial disease: important yet neglected sub-type of atherothrombotic stroke. Int J Stroke. 2013 Apr;8(3):197-203. doi: 10.1111/j.1747-4949.2012.00816.x. Epub 2012 May 9.
- Background Fisher CM. Capsular infarcts: the underlying vascular lesions. Arch Neurol. 1979 Feb;36(2):65-73. doi: 10.1001/archneur.1979.00500380035003.
- Background Caplan LR. Intracranial branch atheromatous disease: a neglected, understudied, and underused concept. Neurology. 1989 Sep;39(9):1246-50. doi: 10.1212/wnl.39.9.1246. No abstract available.
- Liao X, Feng S, Wang Y, Pan Y, Chen W, Qu H, Zhao X, Liu L, Wang Y, Wang Y. Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY): protocol for a multicentre, randomised controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):75-81. doi: 10.1136/svn-2022-002284.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirofiban | Other / unclassified | 0.1 ug/kg | Intravenous |
| Background | Aspirin | Small molecule | 100 mg | — |