October 6, 2009
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October 7, 2009
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October 4, 2018
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December 4, 2018
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December 4, 2018
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May 28, 2010
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April 9, 2018 (Final data collection date for primary outcome measure)
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- Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes [ Time Frame: Up to 90 days ]
Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
- Major Hemorrhage [ Time Frame: Up to 90 days ]
Primary safety outcome: Number of Participants with major hemorrhage
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Major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) [ Time Frame: 90 days ]
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- Ischemic Stroke [ Time Frame: Up to 90 days ]
Secondary efficacy outcome:Number of participants with Ischemic stroke
- Myocardial Infarction [ Time Frame: Up to 90 days ]
Secondary efficacy outcome: Number of participants with Myocardial infarction
- Death From Ischemic Vascular Causes [ Time Frame: Up to 90 days ]
Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
- Ischemic or Hemorrhagic Stroke [ Time Frame: Up to 90 days ]
Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
- Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage [ Time Frame: Up to 90 days ]
Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage
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Secondary Composite Outcome Measure of ischemic stroke, MI, ischemic vascular death, major hemorrhage: This measure will incorporate benefits in terms of reduction in ischemic events with potential risks in terms of increased major hemorrhage [ Time Frame: 90 days ]
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- Hemorrhagic Stroke [ Time Frame: up to 90 days ]
Other safety outcome: Number of participants with Hemorrhagic stroke
- Symptomatic Intracerebral Hemorrhage [ Time Frame: up to 90 days ]
Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage
- Other Symptomatic Intracranial Hemorrhage [ Time Frame: up to 90 days ]
Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage
- Major Hemorrhage Other Than Intracranial Hemorrhage [ Time Frame: up to 90 days ]
Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage
- Minor Hemorrhage [ Time Frame: up to 90 days ]
Other safety outcome:Number of Participants with Minor hemorrhage
- Death From Any Cause [ Time Frame: up to 90 days ]
Other safety outcome: Number of Participants with Death from any cause
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Not Provided
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Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
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Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
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A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).
TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.
Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.
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Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.
Its primary objective is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day (with a dose of 150-200 mg daily for 5 days followed by 75-100 mg daily strongly recommended).
Patients over 18 years of age with high-risk TIA (defined as an ABCD2 score greater than or equal to 4) or minor ischemic stroke (with NIHSS less than or equal to 3) who can be treated within 12 hours of time last known free of new ischemic symptoms will be enrolled.
Subjects will be randomized 1:1 (clopidogrel: placebo), controlling for clinical center. A study participant's eligibility will be determined by site personnel prior to accessing the Randomization Module in the WebDCU™, a web-enabled clinical trials management system that was developed by the NETT Statistics and Data Management Center (SDMC) at Medical University of South Carolina (MUSC).Qualified users will access the Randomization Interface and complete a protocol-specific eligibility checklist. If the Randomization Interface finds the patient to be eligible based on the information provided, a randomization number and a confirmatory e-mail are generated.
Each subject is followed for 90 days from randomization; the trial will be completed in 7 years.
A total of 5,840 patients will be recruited. Recruitment will occur over 90 months, with a goal rate of 0.40 subjects/site/month for US sites, and a goal rate of 0.47 subjects/site/month for OUS sites. Current participating sites can be found at: http://www.pointtrial.org/node/18.
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
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Ischemic Attack, Transient
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- Drug: Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
Other Name: Plavix
- Drug: placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days
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- Active Comparator: clopidogrel
Patients assigned to clopidogrel in addition to aspirin
Intervention: Drug: Clopidogrel
- Placebo Comparator: placebo
Patients assigned to placebo in addition to aspirin
Intervention: Drug: placebo
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- Edlow JA, Kim S, Pelletier AJ, Camargo CA Jr. National study on emergency department visits for transient ischemic attack, 1992-2001. Acad Emerg Med. 2006 Jun;13(6):666-72. Epub 2006 Apr 11.
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- Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. Review.
- Gladstone DJ, Kapral MK, Fang J, Laupacis A, Tu JV. Management and outcomes of transient ischemic attacks in Ontario. CMAJ. 2004 Mar 30;170(7):1099-104.
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- Whisnant JP, Matsumoto N, Elveback LR. Transient cerebral ischemic attacks in a community. Rochester, Minnesota, 1955 through 1969. Mayo Clin Proc. 1973 Mar;48(3):194-8.
- Humphrey PR, Marshall J. Transient ischemic attacks and strokes with recovery prognosis and investigation. Stroke. 1981 Nov-Dec;12(6):765-9.
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- Biller J, Bruno A, Adams HP Jr, Godersky JC, Loftus CM, Mitchell VL, Banwart KJ, Jones MP. A randomized trial of aspirin or heparin in hospitalized patients with recent transient ischemic attacks. A pilot study. Stroke. 1989 Apr;20(4):441-7.
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- 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. Epub 2004 Jan 26.
- Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. Epub 2004 Oct 14.
- Whitehead MA, McManus J, McAlpine C, Langhorne P. Early recurrence of cerebrovascular events after transient ischaemic attack. Stroke. 2005 Jan;36(1):1; author reply 1.
- Correia M, Silva MR, Magalhães R, Guimarães L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. Epub 2005 Dec 1.
- Purroy F, Molina CA, Montaner J, Alvarez-Sabín J. Absence of usefulness of ABCD score in the early risk of stroke of transient ischemic attack patients. Stroke. 2007 Mar;38(3):855-6; author reply 857. Epub 2007 Jan 18.
- Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.
- Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
- Mac Grory B, Piccini JP, Yaghi S, Poli S, De Havenon A, Rostanski SK, Weiss M, Xian Y, Johnston SC, Feng W. Hyperglycemia, Risk of Subsequent Stroke, and Efficacy of Dual Antiplatelet Therapy: A Post Hoc Analysis of the POINT Trial. J Am Heart Assoc. 2022 Feb;11(3):e023223. doi: 10.1161/JAHA.121.023223. Epub 2022 Jan 19.
- Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.
- Kamel H, Zhang C, Kleindorfer DO, Levitan EB, Howard VJ, Howard G, Soliman EZ, Johnston SC. Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):601-605. doi: 10.1001/jamaneurol.2020.0010.
- Cucchiara B, Elm J, Easton JD, Coutts SB, Willey JZ, Biros MH, Ross MA, Johnston SC. Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial. Stroke. 2020 Mar;51(3):792-799. doi: 10.1161/STROKEAHA.119.027465. Epub 2020 Feb 12.
- Farrant M, Easton JD, Adelman EE, Cucchiara BL, Barsan WG, Tillman HJ, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Zhao W, Pauls K, Walsh KB, Martí-Fàbregas J, Bernstein RA, Johnston SC. Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis. JAMA Netw Open. 2019 Sep 4;2(9):e1910769. doi: 10.1001/jamanetworkopen.2019.10769.
- Johnston SC, Elm JJ, Easton JD, Farrant M, Barsan WG, Kim AS, Lindblad AS, Palesch YY, Zurita KG, Albers GW, Cucchiara BL, Kleindorfer DO, Lutsep HL, Pearson C, Sethi P, Vora N; POINT and Neurological Emergencies Treatment Trials Network Investigators. Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke. Circulation. 2019 Aug 20;140(8):658-664. doi: 10.1161/CIRCULATIONAHA.119.040713. Epub 2019 Jun 26.
- Tillman H, Johnston SC, Farrant M, Barsan W, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Easton JD. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):774-782. doi: 10.1001/jamaneurol.2019.0932.
- Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
- Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
- Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.
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Terminated
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4881
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4150
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April 9, 2018
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April 9, 2018 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Australia, Canada, Finland, France, Germany, Mexico, New Zealand, Spain, United Kingdom, United States
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NCT00991029
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1U01S062835-01A1
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Not Provided
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University of California, San Francisco
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S. Claiborne Johnston, MD, PhD, University of California, San Francisco
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University of California, San Francisco
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Same as current
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- Neurological Emergencies Treatment Trials Network (NETT)
- Medical University of South Carolina
- The Emmes Company, LLC
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Principal Investigator: |
S. Claiborne Johnston, MD, PhD |
University of Texas, Austin |
Principal Investigator: |
J. Donald Easton, MD |
University of California, San Francisco |
Principal Investigator: |
Anthony S. Kim, MD, MAS |
University of California, San Francisco |
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University of California, San Francisco
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November 2018
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