Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial (POINT)

November 14, 2018 updated by: University of California, San Francisco

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4881

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia
        • Gosford Hospital
      • New Lambton, New South Wales, Australia
        • John Hunter Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • Epping, Victoria, Australia
        • The Northern Hospital
      • Footscray, Victoria, Australia
        • Footscray Hospital
      • Heidelberg, Victoria, Australia
        • Austin Hospital
      • Parkville, Victoria, Australia
        • Royal Melbourne Hospital
  • Canada
      • Quebec, Canada
        • Enfant-Jésus Hospital
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary - Foothills Campus
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada
        • Grey Nuns Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Center
    • Quebec
      • Greenfield Park, Quebec, Canada
        • Charles LeMoyne Hospital
      • Montreal, Quebec, Canada
        • Montreal General Hospital
      • Montreal, Quebec, Canada
        • Notre-Dame Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Turku, Finland
        • Turku University Hospital
  • France
      • Bourg-en-Bresse, France
        • Fleyriat Hospital
      • Bron, France
        • Pierre Wetheimer Hospital
      • Paris, France
        • Pitié-Salpêtrière Hospital
      • Paris, France
        • Bichat-Claude Bernard Hospital
      • Paris, France
        • Adolphe de Rothschild Ophthalmologic Foundation
      • Suresnes, France
        • Foch Hospital
  • Germany
      • Bad Neustadt an der Saale, Germany
        • Neurological Clinic Bad Neustadt
      • Berlin, Germany
        • Vivantes Hospital Neukölln
      • Bremen, Germany
        • Central Bremen Hospital
      • Essen, Germany
        • University Hospital Essen
      • Frankfurt, Germany
        • University Hospital Frankfurt
      • Hamburg, Germany
        • University Medical Center Hamburg
      • Hannover, Germany
        • Hannover Medical School
      • Heidelberg, Germany
        • University Hospital Heidelberg
      • Kiel, Germany
        • University Hospital Schleswig-Holstein Kiel Campus
      • Leipzig, Germany
        • University Medical Center Leipzig
      • Munster, Germany
        • University Hospital Münster
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • University Hospital of Ulm
  • Mexico
      • Mexico City, Mexico
        • ABC Medical Center Santa Fe
    • Hidalgo
      • Pachuca, Hidalgo, Mexico
        • Mexican Association for Clinical Research
    • San Luis Potosi
      • San Luis Potosí, San Luis Potosi, Mexico, 78240
        • Central Hospital Dr. Ignacio Morones Prieto
    • Sinaloa
      • Culiacan, Sinaloa, Mexico
        • Culiacan General Hospital
      • Culiacan, Sinaloa, Mexico
        • Neurosciences Clinical Trials
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Vall d'Hebron Hospital
      • Barcelona, Spain
        • Santa Creu and Sant Pau Hospital
      • Bilbao, Spain
        • Basurto Hospital
      • Burgos, Spain
        • Burgos University Hospital
      • Donostia, Spain
        • Hospital Donostia
      • Girona, Spain
        • Girona University Hospital
      • Valencia, Spain
        • La Fe University Hospital
      • Zaragoza, Spain
        • Miguel Servet Hospital
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Harrow, United Kingdom
        • Northwick Park Hospital
      • London, United Kingdom
        • The Royal London Hospital
      • London, United Kingdom
        • University College Hospital
      • Luton, United Kingdom
        • Luton and Dunstable University Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Somerset, United Kingdom
        • Royal United Hospital - Bath
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke University Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center - Tucson Campus
    • California
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • La Jolla, California, United States, 92037
        • UCSD Health La Jolla
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Palm Springs, California, United States, 92262
        • Desert Regional Medical Center
      • Pasadena, California, United States, 91105
        • Huntington Memorial Hospital
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • San Diego, California, United States, 92103
        • Scripps Mercy Hospital San Diego
      • San Diego, California, United States, 92103
        • UCSD Medical Center - Hillcrest Hospital
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital and Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Lakewood, Colorado, United States, 80228
        • St. Anthony Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Hospital
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Shands Hospital
      • Jacksonville, Florida, United States, 32209
        • University of Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital
      • Glenview, Illinois, United States, 60026
        • NorthShore Glenbrook Hospital
      • Joliet, Illinois, United States, 60435
        • Presence Saint Joseph Medical Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 62781
        • Southern Illinois University Memorial Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Medical Center South
      • Florence, Kentucky, United States, 41042
        • St. Elizabeth Hospital
      • Fort Thomas, Kentucky, United States, 41075
        • St. Elizabeth Hospital Fort Thomas
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01655
        • Umass Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai-Grace Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Mercy Health Saint Mary's
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford West Bloomfield Hospital
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota Medical Center Hospital
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Saint Mary's Campus
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital
    • Montana
      • Great Falls, Montana, United States, 59405
        • Benefis Hospitals Inc
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic Hospital, Great Falls
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Edison, New Jersey, United States, 08820
        • JFK Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Bronx, New York, United States, 10451
        • Lincoln Medical and Mental Health Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital Center
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
      • New York, New York, United States, 10065
        • NYP Weill Cornell Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian / Columbia University Medical Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14642
        • Strong Memorial Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Guilford Neurologic Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Akron City Hospital
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45219
        • Christ Hospital
      • Cincinnati, Ohio, United States, 45236
        • Jewish Hospital
      • Cincinnati, Ohio, United States, 45211
        • Mercy Health West Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43210
        • OSU Wexner Medical Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University Hospital
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside Hospital
      • York, Pennsylvania, United States, 17403
        • Wellspan York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina University Hospital
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland
    • Tennessee
      • Nashville, Tennessee, United States, 37323
        • Vanderbilt University Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Austin, Texas, United States, 78701
        • University Medical Center Brackenridge
      • Dallas, Texas, United States, 75231
        • Texas Health Presbyterian Hospital - Dallas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center - Harlingen
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Medical Center
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital
      • Richmond, Virginia, United States, 23229
        • Henrico Doctors' Hospital - Forest Campus
      • Richmond, Virginia, United States, 23294
        • Henrico Doctors' Hospital - Parham Campus
      • Richmond, Virginia, United States, 23114
        • Bon Secours St. Francis Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • WVU Healthcare Ruby Memorial Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia St. Mary's Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: clopidogrel
Patients assigned to clopidogrel in addition to aspirin
Drug: Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days
Other Names:
  • Plavix
Placebo Comparator: placebo
Patients assigned to placebo in addition to aspirin
Drug: placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 90 days
Major Hemorrhage
Time Frame: Up to 90 days
Primary safety outcome: Number of Participants with major hemorrhage
Up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic Stroke
Time Frame: Up to 90 days
Secondary efficacy outcome:Number of participants with Ischemic stroke
Up to 90 days
Myocardial Infarction
Time Frame: Up to 90 days
Secondary efficacy outcome: Number of participants with Myocardial infarction
Up to 90 days
Death From Ischemic Vascular Causes
Time Frame: Up to 90 days
Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
Up to 90 days
Ischemic or Hemorrhagic Stroke
Time Frame: Up to 90 days
Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
Up to 90 days
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
Up to 90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhagic Stroke
Time Frame: up to 90 days
Other safety outcome: Number of participants with Hemorrhagic stroke
up to 90 days
Symptomatic Intracerebral Hemorrhage
Time Frame: up to 90 days
Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage
up to 90 days
Other Symptomatic Intracranial Hemorrhage
Time Frame: up to 90 days
Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage
up to 90 days
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
up to 90 days
Minor Hemorrhage
Time Frame: up to 90 days
Other safety outcome:Number of Participants with Minor hemorrhage
up to 90 days
Death From Any Cause
Time Frame: up to 90 days
Other safety outcome: Number of Participants with Death from any cause
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Medical University of South Carolina
The Emmes Company, LLC
Neurological Emergencies Treatment Trials Network (NETT)

Investigators

  • Principal Investigator: S. Claiborne Johnston, MD, PhD, University of Texas - Austin
  • Principal Investigator: J. Donald Easton, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2010

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

April 9, 2018

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01S062835-01A1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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