Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
NCT ID: NCT00991029
Last Updated: 2018-12-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
4881 participants
INTERVENTIONAL
2010-05-28
2018-04-09
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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clopidogrel
Patients assigned to clopidogrel in addition to aspirin
Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
placebo
Patients assigned to placebo in addition to aspirin
placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days
Interventions
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Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score of (greater than or equal to) 4 OR
* Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3 at the time of randomization
* Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
* Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
* Ability to tolerate aspirin at a does of 50-325 mg/day.
Exclusion Criteria
* TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
* In the judgment of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
* Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
* Gastrointestinal bleed or major surgery within 3 months prior to index event.
* History of nontraumatic intracranial hemorrhage.
* Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
* Qualifying ischemic event induced by angiography or surgery.
* Severe non-cardiovascular comorbidity with life expectancy \<3 months.
* Contraindication to clopidogrel or aspirin.
* Known allergy
* Severe renal (serum creatinine \>2 mg/dL or 176.8umol/L) or hepatic insufficiency (prior or concurrent diagnosis, with International Normalized Ratio (INR)\>1.5 or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
* Hemostatic disorder or systemic bleeding in the past 3 months
* Current thrombocytopenia (platelet count \<100 x10\^9/l) or neutropenia (\<1 x10\^9/l)
* History of drug-induced hematologic or hepatic abnormalities
* Anticipated requirement for long-term (\>7 day) non-study antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).
* Inability to swallow medications.
* At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
* Unavailability for follow-up.
* Signed and dated informed consent not obtained from patient.
* Other neurological conditions that would complicate assessment of outcomes during follow-up.
* Ongoing treatment in another study of an investigational therapy that may potentially interact with study drug, or treatment in such a study within the last 7 days.
* Previously enrolled in the POINT study.
18 Years
ALL
No
Sponsors
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Neurological Emergencies Treatment Trials Network (NETT)
NETWORK
Medical University of South Carolina
OTHER
The Emmes Company, LLC
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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S. Claiborne Johnston, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas - Austin
J. Donald Easton, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Anthony S. Kim, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Chandler Regional Medical Center
Chandler, Arizona, United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States
Mercy San Juan Medical Center
Carmichael, California, United States
UCSD Health La Jolla
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
UC Davis Medical Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Scripps Mercy Hospital San Diego
San Diego, California, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
San Francisco General Hospital
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
St. Anthony Hospital
Lakewood, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
UF Health Shands Hospital
Gainesville, Florida, United States
University of Florida
Jacksonville, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
the Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois Hospital
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
NorthShore Glenbrook Hospital
Glenview, Illinois, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Southern Illinois University Memorial Medical Center
Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
St. Elizabeth Medical Center South
Edgewood, Kentucky, United States
St. Elizabeth Hospital
Florence, Kentucky, United States
St. Elizabeth Hospital Fort Thomas
Fort Thomas, Kentucky, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Hospital
Minneapolis, Minnesota, United States
Mayo Clinic Saint Mary's Campus
Rochester, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Mercy Hospital
Springfield, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Mercy Hospital
St Louis, Missouri, United States
Benefis Hospitals Inc
Great Falls, Montana, United States
Great Falls Clinic Hospital, Great Falls
Great Falls, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
JFK Medical Center
Edison, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
New York Presbyterian / Columbia University Medical Center
New York, New York, United States
NYP Weill Cornell Medical Center
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Summa Akron City Hospital
Akron, Ohio, United States
Mercy Health West Hospital
Cincinnati, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Jewish Hospital
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University Hospital
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Pennsylvania State Hershey Medical Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Palmetto Health Richland
Columbia, South Carolina, United States
Vanderbilt University Hospital
Nashville, Tennessee, United States
University Medical Center Brackenridge
Austin, Texas, United States
Seton Medical Center
Austin, Texas, United States
Texas Health Presbyterian Hospital - Dallas
Dallas, Texas, United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
UVA Medical Center
Charlottesville, Virginia, United States
Bon Secours St. Francis Medical Center
Richmond, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, United States
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, United States
Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Gosford Hospital
Gosford, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Northern Hospital
Epping, Victoria, Australia
Footscray Hospital
Footscray, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
University of Calgary - Foothills Campus
Calgary, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
London Health Sciences Center
London, Ontario, Canada
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Notre-Dame Hospital
Montreal, Quebec, Canada
Enfant-Jesus Hospital
Québec, , Canada
Helsinki University Central Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Fleyriat Hospital
Bourg-en-Bresse, , France
Pierre Wetheimer Hospital
Bron, , France
Adolphe de Rothschild Ophthalmologic Foundation
Paris, , France
Bichat-Claude Bernard Hospital
Paris, , France
Pitie-Salpetriere Hospital
Paris, , France
Foch Hospital
Suresnes, , France
University Hospital of Ulm
Ulm, Baden-Wurttemberg, Germany
Neurological Clinic Bad Neustadt
Bad Neustadt an der Saale, , Germany
Vivantes Hospital Neukolln
Berlin, , Germany
Central Bremen Hospital
Bremen, , Germany
University Hospital Essen
Essen, , Germany
University Hospital Frankfurt
Frankfurt, , Germany
University Medical Center Hamburg
Hamburg, , Germany
Hannover Medical School
Hanover, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University Hospital Schleswig-Holstein Kiel Campus
Kiel, , Germany
University Medical Center Leipzig
Leipzig, , Germany
University Hospital Munster
Münster, , Germany
Mexican Association for Clinical Research
Pachuca, Hidalgo, Mexico
Central Hospital Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, Mexico
Culiacan General Hospital
Culiacán, Sinaloa, Mexico
Neurosciences Clinical Trials
Culiacán, Sinaloa, Mexico
ABC Medical Center Santa Fe
Mexico City, , Mexico
Auckland City Hospital
Auckland, , New Zealand
Hospital del Mar
Barcelona, , Spain
Santa Creu and Sant Pau Hospital
Barcelona, , Spain
Vall d'Hebron Hospital
Barcelona, , Spain
Basurto Hospital
Bilbao, , Spain
Burgos University Hospital
Burgos, , Spain
Hospital Donostia
Donostia / San Sebastian, , Spain
Girona University HOspital
Girona, , Spain
La Fe University Hospital
Valencia, , Spain
Miguel Servet Hospital
Zaragoza, , Spain
Addenbrooke's Hospital
Cambridge, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
The Royal London Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Luton and Dunstable University Hospital
Luton, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Royal United Hospital - Bath
Somerset, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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References
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Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18.
Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.
Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1. doi: 10.1016/S1474-4422(07)70249-1. No abstract available.
Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4. doi: 10.1136/hrt.2007.121111.
Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27. No abstract available.
Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400. doi: 10.1016/S0140-6736(07)61449-4. No abstract available.
Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.
Geisler T, Zurn C, Paterok M, Gohring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.
Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.
Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. doi: 10.1161/01.CIR.0000124581.18191.15. Epub 2004 Mar 15.
Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barilla F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.
Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. doi: 10.1016/j.jacc.2007.01.097. Epub 2007 Jul 10.
Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. doi: 10.1161/01.CIR.0000088780.57432.43. Epub 2003 Aug 18.
Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Buttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.
Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.
Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.
Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54. doi: 10.1002/ana.20497.
Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9. No abstract available.
Lavallee PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Leseche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60. doi: 10.1016/S1474-4422(07)70248-X.
Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.
Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.
Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.
Brown RD Jr, Petty GW, O'Fallon WM, Wiebers DO, Whisnant JP. Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989. Stroke. 1998 Oct;29(10):2109-13. doi: 10.1161/01.str.29.10.2109.
Kissela B, Broderick J, Woo D, Kothari R, Miller R, Khoury J, Brott T, Pancioli A, Jauch E, Gebel J, Shukla R, Alwell K, Tomsick T. Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study. Stroke. 2001 Jun;32(6):1285-90. doi: 10.1161/01.str.32.6.1285.
Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999 Dec;30(12):2523-8. doi: 10.1161/01.str.30.12.2523.
Kleindorfer D, Panagos P, Pancioli A, Khoury J, Kissela B, Woo D, Schneider A, Alwell K, Jauch E, Miller R, Moomaw C, Shukla R, Broderick JP. Incidence and short-term prognosis of transient ischemic attack in a population-based study. Stroke. 2005 Apr;36(4):720-3. doi: 10.1161/01.STR.0000158917.59233.b7. Epub 2005 Feb 24.
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. doi: 10.1197/j.aem.2006.01.014. Epub 2006 Apr 11.
Howard G, Toole JF, Frye-Pierson J, Hinshelwood LC. Factors influencing the survival of 451 transient ischemic attack patients. Stroke. 1987 May-Jun;18(3):552-7. doi: 10.1161/01.str.18.3.552.
Shah KH, Kleckner K, Edlow JA. Short-term prognosis of stroke among patients diagnosed in the emergency department with a transient ischemic attack. Ann Emerg Med. 2008 Mar;51(3):316-23. doi: 10.1016/j.annemergmed.2007.08.016. Epub 2007 Oct 25.
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. doi: 10.1001/archinte.167.22.2417.
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. doi: 10.1503/cmaj.1031349.
Lisabeth LD, Ireland JK, Risser JM, Brown DL, Smith MA, Garcia NM, Morgenstern LB. Stroke risk after transient ischemic attack in a population-based setting. Stroke. 2004 Aug;35(8):1842-6. doi: 10.1161/01.STR.0000134416.89389.9d. Epub 2004 Jun 10.
Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9. doi: 10.1503/cmaj.1030460.
Hill MD, Yiannakoulias N, Jeerakathil T, Tu JV, Svenson LW, Schopflocher DP. The high risk of stroke immediately after transient ischemic attack: a population-based study. Neurology. 2004 Jun 8;62(11):2015-20. doi: 10.1212/01.wnl.0000129482.70315.2f.
Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36. doi: 10.1016/S0140-6736(05)66702-5.
Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.
Rao SV, Ohman EM, Granger CB, Armstrong PW, Gibler WB, Christenson RH, Hasselblad V, Stebbins A, McNulty S, Newby LK. Prognostic value of isolated troponin elevation across the spectrum of chest pain syndromes. Am J Cardiol. 2003 Apr 15;91(8):936-40. doi: 10.1016/s0002-9149(03)00107-3.
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. No abstract available.
Humphrey PR, Marshall J. Transient ischemic attacks and strokes with recovery prognosis and investigation. Stroke. 1981 Nov-Dec;12(6):765-9. doi: 10.1161/01.str.12.6.765.
Putman SF, Adams HP Jr. Usefulness of heparin in initial management of patients with recent transient ischemic attacks. Arch Neurol. 1985 Oct;42(10):960-2. doi: 10.1001/archneur.1985.04060090042011.
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. doi: 10.1161/01.str.20.4.441.
Dennis M, Bamford J, Sandercock P, Warlow C. Prognosis of transient ischemic attacks in the Oxfordshire Community Stroke Project. Stroke. 1990 Jun;21(6):848-53. doi: 10.1161/01.str.21.6.848.
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.
Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. doi: 10.1161/01.STR.0000144050.90132.8e. 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. doi: 10.1161/01.str.0000149929.92356.f1. No abstract available.
Correia M, Silva MR, Magalhaes R, Guimaraes L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. doi: 10.1161/01.STR.0000195209.26543.8f. Epub 2005 Dec 1.
Purroy F, Molina CA, Montaner J, Alvarez-Sabin 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. doi: 10.1161/01.STR.0000257306.00512.d3. Epub 2007 Jan 18. No abstract available.
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.
Balali P, Easton JD, Johnston SC, Cucchiara B. Time to treatment and disability attributed to index stroke in the POINT trial. J Stroke Cerebrovasc Dis. 2024 Nov;33(11):107988. doi: 10.1016/j.jstrokecerebrovasdis.2024.107988. Epub 2024 Sep 1.
Daghlas I, Johnston SC, Easton JD, Kim AS. Baseline Stroke Risk and Efficacy of Dual-Antiplatelet Therapy: A Post Hoc Analysis of the POINT Trial. Stroke. 2024 Feb;55(2):385-391. doi: 10.1161/STROKEAHA.123.044927. Epub 2024 Jan 4.
Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.
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, Marti-Fabregas 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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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
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1U01S062835-01A1
Identifier Type: -
Identifier Source: org_study_id
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