Study Stopped
The trial was halted by the DSMB.
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
POINT
1 other identifier
interventional
4,881
10 countries
210
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2010
Longer than P75 for phase_3
210 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedStudy Start
First participant enrolled
May 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2018
CompletedResults Posted
Study results publicly available
December 4, 2018
CompletedDecember 4, 2018
November 1, 2018
7.9 years
October 6, 2009
October 4, 2018
November 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Up to 90 days
Major Hemorrhage
Primary safety outcome: Number of Participants with major hemorrhage
Up to 90 days
Secondary Outcomes (5)
Ischemic Stroke
Up to 90 days
Myocardial Infarction
Up to 90 days
Death From Ischemic Vascular Causes
Up to 90 days
Ischemic or Hemorrhagic Stroke
Up to 90 days
Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage
Up to 90 days
Other Outcomes (6)
Hemorrhagic Stroke
up to 90 days
Symptomatic Intracerebral Hemorrhage
up to 90 days
Other Symptomatic Intracranial Hemorrhage
up to 90 days
- +3 more other outcomes
Study Arms (2)
clopidogrel
ACTIVE COMPARATORPatients assigned to clopidogrel in addition to aspirin
placebo
PLACEBO COMPARATORPatients assigned to placebo in addition to aspirin
Interventions
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
Eligibility Criteria
You may qualify if:
- Neurological deficit (based on history or exam) attributed to focal brain ischemia and EITHER:
- 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.
You may not qualify if:
- Age \<18 years
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Neurological Emergencies Treatment Trials Network (NETT)collaborator
- Medical University of South Carolinacollaborator
- The Emmes Company, LLCcollaborator
Study Sites (210)
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Banner University Medical Center - Tucson Campus
Tucson, Arizona, 85724, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
UCSD Health La Jolla
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Scripps Mercy Hospital San Diego
San Diego, California, 92103, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
St. Anthony Hospital
Lakewood, Colorado, 80228, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Christiana Hospital
Newark, Delaware, 19713, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
UF Health Shands Hospital
Gainesville, Florida, 32608, United States
University of Florida
Jacksonville, Florida, 32209, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
the Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Hospital
Chicago, Illinois, 60612, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Evanston Hospital
Evanston, Illinois, 60201, United States
NorthShore Glenbrook Hospital
Glenview, Illinois, 60026, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, 60435, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Southern Illinois University Memorial Medical Center
Springfield, Illinois, 62781, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
St. Elizabeth Medical Center South
Edgewood, Kentucky, 41017, United States
St. Elizabeth Hospital
Florence, Kentucky, 41042, United States
St. Elizabeth Hospital Fort Thomas
Fort Thomas, Kentucky, 41075, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Sinai-Grace Hospital
Detroit, Michigan, 48235, United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
University of Minnesota Medical Center Hospital
Minneapolis, Minnesota, 55454, United States
Mayo Clinic Saint Mary's Campus
Rochester, Minnesota, 55902, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Mercy Hospital
Springfield, Missouri, 65804, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Benefis Hospitals Inc
Great Falls, Montana, 59405, United States
Great Falls Clinic Hospital, Great Falls
Great Falls, Montana, 59405, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
JFK Medical Center
Edison, New Jersey, 08820, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
New York Presbyterian / Columbia University Medical Center
New York, New York, 10032, United States
NYP Weill Cornell Medical Center
New York, New York, 10065, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Summa Akron City Hospital
Akron, Ohio, 44304, United States
Mercy Health West Hospital
Cincinnati, Ohio, 45211, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University Hospital
Portland, Oregon, 97239, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Pennsylvania State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
WellSpan York Hospital
York, Pennsylvania, 17403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, 29425, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Vanderbilt University Hospital
Nashville, Tennessee, 37323, United States
University Medical Center Brackenridge
Austin, Texas, 78701, United States
Seton Medical Center
Austin, Texas, 78705, United States
Texas Health Presbyterian Hospital - Dallas
Dallas, Texas, 75231, United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, 78550, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
UVA Medical Center
Charlottesville, Virginia, 22908, United States
Bon Secours St. Francis Medical Center
Richmond, Virginia, 23114, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226, United States
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, 23229, United States
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, 23294, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26505, United States
Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53211, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, 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, 89081, 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, 78240, 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
Related Publications (62)
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.
PMID: 18207691BACKGROUNDGiles 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.
PMID: 17993293BACKGROUNDKernan 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.
PMID: 17928271BACKGROUNDRothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4. doi: 10.1136/hrt.2007.121111.
PMID: 17639101BACKGROUNDStreifler 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.
PMID: 18369165BACKGROUNDDean 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.
PMID: 17928045BACKGROUNDKennedy 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.
PMID: 17931979BACKGROUNDGeisler 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.
PMID: 18503057BACKGROUNDLotfi 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.
PMID: 18440347BACKGROUNDMitsios 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.
PMID: 15023882BACKGROUNDRiondino 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.
PMID: 18636229BACKGROUNDSaw 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.
PMID: 17659194BACKGROUNDSaw 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.
PMID: 12925453BACKGROUNDTrenk 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.
PMID: 18217151BACKGROUNDJohnston 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.
PMID: 11147987BACKGROUNDCoutts 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.
PMID: 18705908BACKGROUNDCoutts 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.
PMID: 15929051BACKGROUNDAlgra 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.
PMID: 18275919BACKGROUNDLavallee 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.
PMID: 17928270BACKGROUNDLuengo-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.
PMID: 19200786BACKGROUNDYusuf 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.
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PMID: 20826243BACKGROUNDWang 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.
PMID: 23803136BACKGROUNDBalali 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.
PMID: 39222701DERIVEDDaghlas 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.
PMID: 38174567DERIVEDDiener 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.
PMID: 35538232DERIVEDMac 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.
PMID: 35043692DERIVEDMeschia 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.
PMID: 32568642DERIVEDKamel 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.
PMID: 32091536DERIVEDCucchiara 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.
PMID: 32078486DERIVEDFarrant 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.
PMID: 31490536DERIVEDJohnston 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.
PMID: 31238700DERIVEDTillman 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.
PMID: 31034032DERIVEDJohnston 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.
PMID: 29766750DERIVEDZhao 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.
PMID: 26464429DERIVEDJohnston 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.
PMID: 23879752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jordan Elm
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
S. Claiborne Johnston, MD, PhD
University of Texas at Austin
- PRINCIPAL INVESTIGATOR
J. Donald Easton, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Anthony S. Kim, MD, MAS
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 7, 2009
Study Start
May 28, 2010
Primary Completion
April 9, 2018
Study Completion
April 9, 2018
Last Updated
December 4, 2018
Results First Posted
December 4, 2018
Record last verified: 2018-11