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Trial record 2 of 13494 for:    POINT

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

This study is currently recruiting participants.
Verified August 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991029
First Posted: October 7, 2009
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
The EMMES Corporation
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

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.


Condition Intervention Phase
Ischemic Attack, Transient Drug: Clopidogrel Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • New ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • secondary outcomes will be evaluated, separately including risk of ischemic stroke, intracranial hemorrhage, and major hemorrhage, and the composite of the primary outcome and major hemorrhage. [ Time Frame: 90 days ]

Estimated Enrollment: 5840
Study Start Date: October 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991029


Contacts
Contact: Mary Farrant, MBA, BSN, RN 415-502-7304 mary.farrant2@ucsf.edu

  Hide Study Locations
Locations
United States, Arizona
Chandler Regional Medical Center Recruiting
Chandler, Arizona, United States, 85224
Principal Investigator: Brian Tiffany, MD         
Banner University Medical Center - Tucson Campus Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Kendra Drake, MD         
United States, California
Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Principal Investigator: Lucian Maidan, MD         
UCSD Health La Jolla Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Dawn Meyer, NP,PhD         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Principal Investigator: Vincent V Truong, MD         
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Principal Investigator: Nima Ramezan-Arab, MD         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Zahra Ajani, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Shlee S Song, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Sidney Starkman, MD         
Desert Regional Medical Center Recruiting
Palm Springs, California, United States, 92262
Principal Investigator: Luis T Arangua, MD         
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91105
Principal Investigator: Arbi Ohanian, MD         
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Daniel Nishijima, MD,MAS         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Principal Investigator: Lucian Maidan, MD         
Scripps Mercy Hospital San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Royya Modir, MD         
UCSD Medical Center - Hillcrest Hospital Recruiting
San Diego, California, United States, 92103
Principal Investigator: Dawn Meyer, NP,PhD         
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Principal Investigator: Claude J Hemphill, MD         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Wade Smith, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Principal Investigator: Gergory W Albers, MD         
Los Robles Hospital and Medical Center Recruiting
Thousand Oaks, California, United States, 91360
Principal Investigator: M Asif Taqi, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Jennifer Simpson, MD         
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Principal Investigator: Ira Chang, MD         
St. Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Principal Investigator: Mark M Murray, MD,PhD         
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Joseph L Schindler, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19713
Principal Investigator: Jason T Nomura, MD         
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20037
Principal Investigator: Kathleen Burger, DO         
United States, Florida
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32608
Principal Investigator: Anna Khanna, MD         
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Principal Investigator: Scott L Silliman, MD         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Principal Investigator: Mauricio Concha, MD         
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Michael A Ross, MD         
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Michael A Ross, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Michael A Ross, MD         
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Jeffrey Switzer, MD         
United States, Hawaii
the Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Principal Investigator: Rony N Salem, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Richard Bernstein, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: James J Conners, MD,MS         
University of Illinois Hospital Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Fernando D Testai, MD         
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Principal Investigator: Franklin A Marden, MD,FAHA,FAAN         
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Archie L Ong, MD         
NorthShore Glenbrook Hospital Recruiting
Glenview, Illinois, United States, 60026
Principal Investigator: Archie L Ong, MD         
Presence Saint Joseph Medical Center Recruiting
Joliet, Illinois, United States, 60435
Principal Investigator: Aamir Badruddin, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Michael Schneck, MD,FAHA,FAAN         
Southern Illinois University Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Principal Investigator: Fazeel Siddiqui, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Harold P Adams Jr., MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Michael Abraham, MD         
United States, Kentucky
St. Elizabeth Medical Center South Recruiting
Edgewood, Kentucky, United States, 41017
Principal Investigator: Kyle Walsh, MD         
St. Elizabeth Hospital Recruiting
Florence, Kentucky, United States, 41042
Principal Investigator: Kyle Walsh, MD         
St. Elizabeth Hospital Fort Thomas Recruiting
Fort Thomas, Kentucky, United States, 41075
Principal Investigator: Kyle Walsh, MD         
University of Kentucky Hospital Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Roger L Humphries, MD         
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Wei Liu, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Carolyn A Cronin, MD         
Frederick Memorial Hospital Recruiting
Frederick, Maryland, United States, 21701
Principal Investigator: Shahid Rafiq, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Scott B Silverman, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Daniel J Pallin, MD,MPH         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Jose R Romero, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Nathan I Shapiro, MD,MPH         
UMASS Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Majaz Moonis, MD         
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Anthony T Lagina, MD         
Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Anthony T Lagina, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Hebah Hefzy, MD         
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Principal Investigator: Anthony T Lagina, MD         
St. John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Principal Investigator: Claire Pearson, MD         
Mercy Health Saint Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Muhammad U Farooq, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Robert A Swor, DO         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48085
Principal Investigator: Aveh Bastani, MD         
Henry Ford West Bloomfield Hospital Recruiting
West Bloomfield Township, Michigan, United States, 48322
Principal Investigator: Hebah Hefzy, MD         
United States, Minnesota
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Principal Investigator: Mustapha A Ezzeddine, MD         
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Mark Young         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Principal Investigator: Mustapha A Ezzeddine, MD         
University of Minnesota Medical Center Hospital Recruiting
Minneapolis, Minnesota, United States, 55454
Principal Investigator: Mustapha A Ezzeddine, MD         
Mayo Clinic Saint Mary's Campus Recruiting
Rochester, Minnesota, United States, 55902
Principal Investigator: Fernanda Bellolio, MD         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Principal Investigator: Sandra Hanson, MD         
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Peter D Panagos, MD         
Mercy Hospital Recruiting
Saint Louis, Missouri, United States, 63141
Principal Investigator: William R Logan, MD         
Mercy Hospital Recruiting
Springfield, Missouri, United States, 65804
Principal Investigator: Robert S Duff, MD         
United States, Montana
Benefis Hospitals Inc Recruiting
Great Falls, Montana, United States, 59405
Principal Investigator: Dennis W Dietrich, MD         
Great Falls Clinic Hospital, Great Falls Recruiting
Great Falls, Montana, United States, 59405
Principal Investigator: Dennis Dietrich, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Principal Investigator: Timothy G Lukovits, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Principal Investigator: Thomas Mirsen, MD         
JFK Medical Center Recruiting
Edison, New Jersey, United States, 08820
Principal Investigator: Spozhmy Panezai, MD         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Chinwe H Ogedegbe, MD         
Jersey Shore University Medical Center Recruiting
Neptune City, New Jersey, United States, 07753
Principal Investigator: Stephen Martino, MD         
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Deviyani Mehta, MD         
United States, New York
Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
Principal Investigator: Susan W Law, DO,MPH         
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Principal Investigator: Adrian Marchidann, MD         
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Principal Investigator: Steven Rudolph, MD         
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Marilou I Ching, MD         
New York Presbyterian / Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Joshua Z Willey, MD,MS         
NYP Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Principal Investigator: Babak Navi, MD         
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Principal Investigator: Kelly S Matmati, MD         
Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Adam G Kelly, MD         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Principal Investigator: Ethan Brandler, MD,MPH,FACEP         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Julius-Gene S Latorre, MD,MPH         
Lincoln Medical and Mental Health Center Recruiting
The Bronx, New York, United States, 10451
Principal Investigator: Shekar Murthy, MD         
United States, North Carolina
Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27405
Principal Investigator: Pramod Sethi, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Patrick S Reynolds, MD         
United States, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Principal Investigator: Susana Bowling, MD         
Mercy Health West Hospital Recruiting
Cincinnati, Ohio, United States, 45211
Principal Investigator: Kyle B Walsh, MD         
Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Kyle Walsh, MD         
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Kyle Walsh, MD         
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Kyle Walsh, MD         
Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45236
Principal Investigator: Kyle Walsh, MD         
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Principal Investigator: Kyle Walsh, MD         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Joseph P Hanna, MD,MBA         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Irene Katzan, MD,MS         
OSU Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Michel T Torbey, MD,MPH,FCCM         
Mount Carmel East Hospital Recruiting
Columbus, Ohio, United States, 43213
Principal Investigator: Regan Miller, MD,MHA         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Principal Investigator: Bradley S Jacobs, MD         
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Principal Investigator: Mouhammad A Jumaa, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Principal Investigator: Amit Kansara, MD         
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Principal Investigator: Amit Kansara, MD         
Oregon Health and Science University Hospital Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Helmi Lutsep, MD         
Portland VA Medical Center Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Helmi Lutsep, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Principal Investigator: Dan Gzesh, MD         
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Principal Investigator: Frank-Chen Zhang, MD,PhD         
Pennsylvania State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Raymond K Reichwein III, MD         
Hahnemann University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Principal Investigator: Ralph J Riviello, MD,MS,FACEP         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Brett L Cucchiara, MD         
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Brett L Cucchiara, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Brett Cucchiara, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: AnnaMarie Chang, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Nina T Gentile, MD         
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Matthew T Starr, MD         
UPMC Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Matthew T Starr, MD         
WellSpan York Hospital Recruiting
York, Pennsylvania, United States, 17403
Principal Investigator: Erik Kochert, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Shadi Yaghi, MD         
United States, South Carolina
Medical University of South Carolina University Hospital Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Christine A Holmstedt, DO         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Principal Investigator: Souvik Sen, MD,MPH         
United States, Tennessee
Vanderbilt University Hospital Recruiting
Nashville, Tennessee, United States, 37323
Principal Investigator: Howard S Kirshner, MD         
United States, Texas
University Medical Center Brackenridge Recruiting
Austin, Texas, United States, 78701
Principal Investigator: Truman J Milling Jr., MD         
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Principal Investigator: Truman J Milling, Jr., MD         
Texas Health Presbyterian Hospital - Dallas Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Samir H Shah, MD         
Valley Baptist Medical Center - Harlingen Recruiting
Harlingen, Texas, United States, 78550
Principal Investigator: Ameer Hassan, DO,FAHA         
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Dick C Kuo, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: David Chiu, MD         
Memorial Hermann Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Elizabeth K Jones, MD         
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Reza Behrouz, DO         
United States, Virginia
UVA Medical Center Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Nina J Solenski, MD         
Bon Secours St. Francis Medical Center Recruiting
Richmond, Virginia, United States, 23114
Principal Investigator: Amandeep Sangha, MD         
Bon Secours St. Mary's Hospital Recruiting
Richmond, Virginia, United States, 23226
Principal Investigator: Amandeep Sangha, MD         
Henrico Doctors' Hospital - Forest Campus Recruiting
Richmond, Virginia, United States, 23229
Principal Investigator: Alan E Schulman, MD         
Henrico Doctors' Hospital - Parham Campus Recruiting
Richmond, Virginia, United States, 23294
Principal Investigator: Alan E Schulman, MD         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: David L Tirschwell, MD,M.Sc         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: David L Tirschwell, MD,M.Sc         
United States, West Virginia
WVU Healthcare Ruby Memorial Hospital Recruiting
Morgantown, West Virginia, United States, 26505
Principal Investigator: John Brick, MD         
United States, Wisconsin
Columbia St. Mary's Hospital Recruiting
Milwaukee, Wisconsin, United States, 53211
Principal Investigator: Tom P Aufderheide, MD         
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Khaled Asi, MD         
Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: John R Lynch, MD         
Australia, New South Wales
Gosford Hospital Recruiting
Gosford, New South Wales, Australia
Principal Investigator: Bill O'Brien, MBBS         
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia
Principal Investigator: Chris Levi, MBBS         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Principal Investigator: Timothy Kleinig, MBBS,PhD         
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia
Principal Investigator: Chris Bladin, MBBS,FRACP         
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Principal Investigator: Thanh Phan, MBBS         
The Northern Hospital Recruiting
Epping, Victoria, Australia
Principal Investigator: Douglas Crompton, MA,MBBS,PhD         
Footscray Hospital Recruiting
Footscray, Victoria, Australia
Principal Investigator: Tissa Wijeratne, MD,FAAN,FAHA         
Austin Hospital Recruiting
Heidelberg, Victoria, Australia
Principal Investigator: Vincent Thijs         
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia
Principal Investigator: Stephen Davis, MBBS         
Canada, Alberta
University of Calgary - Foothills Campus Recruiting
Calgary, Alberta, Canada
Principal Investigator: Shelagh Coutts, MD,MSc,ChB         
Grey Nuns Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Muzzaffar Siddiqui, MD         
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Ashfaq Shuaib, MD,FRCPC         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Samuel Yip, MD,PhD         
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada
Principal Investigator: Richard Chan, MBBS,FRCPC         
Canada, Quebec
Charles LeMoyne Hospital Recruiting
Greenfield Park, Quebec, Canada
Principal Investigator: Jean-Martin Boulanger, MD,FRCPC         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Principal Investigator: Theodore Wein, MD,FRCPC         
Notre-Dame Hospital Recruiting
Montreal, Quebec, Canada
Principal Investigator: Celine Odier, MD         
Canada
Enfant-Jesus Hospital Recruiting
Quebec, Canada
Principal Investigator: Steve Verreault, MD,FRCPC         
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Principal Investigator: Turgut Tatlisumak, MD,PhD,FAHA         
Turku University Hospital Recruiting
Turku, Finland
Principal Investigator: Risto Roine, MD,PhD         
France
Fleyriat Hospital Recruiting
Bourg-en-Bresse, France
Principal Investigator: Frederic Philippeau, MD         
Pierre Wetheimer Hospital Recruiting
Bron, France
Principal Investigator: Norbert Nighoghossian, MD         
Adolphe de Rothschild Ophthalmologic Foundation Recruiting
Paris, France
Principal Investigator: Michael Obadia, MD,MSc         
Bichat-Claude Bernard Hospital Recruiting
Paris, France
Principal Investigator: Elena Meseguer, MD         
Pitie-Salpetriere Hospital Recruiting
Paris, France
Principal Investigator: Yves Samson, MD         
Foch Hospital Recruiting
Suresnes, France
Principal Investigator: Bertrand Lapergue, MD,PhD         
Germany
University Hospital of Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Principal Investigator: Katharina Althaus, MD         
Neurological Clinic Bad Neustadt Recruiting
Bad Neustadt an der Saale, Germany
Principal Investigator: Hassan Soda, MD         
Vivantes Hospital Neukolln Recruiting
Berlin, Germany
Principal Investigator: Darius G Nabavi, MD         
Central Bremen Hospital Recruiting
Bremen, Germany
Principal Investigator: Andreas Kastrup, MD         
University Hospital Essen Recruiting
Essen, Germany
Principal Investigator: Hans-Christoph Diener, MD,PhD         
University Hospital Frankfurt Recruiting
Frankfurt, Germany
Principal Investigator: Waltraud Pfeilschifter, MD         
University Medical Center Hamburg Recruiting
Hamburg, Germany
Principal Investigator: Gotz Thomalla, MD         
Hannover Medical School Recruiting
Hannover, Germany
Principal Investigator: Karin Weissenborn, MD         
University Hospital Heidelberg Recruiting
Heidelberg, Germany
Principal Investigator: Peter Ringleb, MD         
University Hospital Schleswig-Holstein Kiel Campus Recruiting
Kiel, Germany
Principal Investigator: Andreas Binder, MD         
University Medical Center Leipzig Recruiting
Leipzig, Germany
Principal Investigator: Dominik Michalski, MD         
University Hospital Munster Recruiting
Munster, Germany
Principal Investigator: Rainer Dziewas, MD,PhD         
Mexico
Mexican Association for Clinical Research Recruiting
Pachuca, Hidalgo, Mexico
Principal Investigator: Enrique Vera Jimenez, MD         
Central Hospital Dr. Ignacio Morones Prieto Recruiting
San Luis Potosí, San Luis Potosi, Mexico, 78240
Principal Investigator: Ildefonso Rodriguez Leyva, MD         
Culiacan General Hospital Recruiting
Culiacan, Sinaloa, Mexico
Principal Investigator: Jorge Villarreal-Careaga, MD         
Neurosciences Clinical Trials Recruiting
Culiacan, Sinaloa, Mexico
Principal Investigator: Elmer Guillermo Lopez Meza, MD         
ABC Medical Center Santa Fe Recruiting
Mexico City, Mexico
Principal Investigator: Juan Manuel Calleja Castillo, MD         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Principal Investigator: Alan Barber, MBChB,PhD         
Spain
Hospital del Mar Recruiting
Barcelona, Spain
Principal Investigator: Jaume Roquer, MD,PhD         
Santa Creu and Sant Pau Hospital Recruiting
Barcelona, Spain
Principal Investigator: Joan Marti Fabregas, MD         
Vall d'Hebron Hospital Recruiting
Barcelona, Spain
Principal Investigator: Carlos Molina, MD,PhD         
Basurto Hospital Recruiting
Bilbao, Spain
Principal Investigator: Maria del Mar Freijo Guerrero, MD         
Burgos University Hospital Recruiting
Burgos, Spain
Principal Investigator: Yolanda Bravo Anguiano, MD         
Hospital Donostia Recruiting
Donostia, Spain
Principal Investigator: Ana Maria de Arce Borda         
Girona University HOspital Recruiting
Girona, Spain
Principal Investigator: Joaquin Serena, MD,PhD         
La Fe University Hospital Recruiting
Valencia, Spain
Principal Investigator: Aida Lago, MD,PhD         
Miguel Servet Hospital Recruiting
Zaragoza, Spain
Principal Investigator: Javier Marta-Moreno, MD,PhD         
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Principal Investigator: Kayvan Khadjooi, MD         
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Principal Investigator: Keith Muir, MD         
Northwick Park Hospital Recruiting
Harrow, United Kingdom
Principal Investigator: David Cohen, MD         
The Royal London Hospital Recruiting
London, United Kingdom
Principal Investigator: Saeed Al-Saaedi, MD         
University College Hospital Recruiting
London, United Kingdom
Principal Investigator: Richard Perry, MD,MB,FRCP         
Luton and Dunstable University Hospital Recruiting
Luton, United Kingdom
Principal Investigator: Lakshmanan Sekaran, MD         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Principal Investigator: James Kennedy, MD         
Royal United Hospital - Bath Recruiting
Somerset, United Kingdom
Principal Investigator: Lukuman Gbadamoshi, MD         
Southampton General Hospital Recruiting
Southampton, United Kingdom
Principal Investigator: Nic Weir, MD,MSc         
Royal Stoke University Hospital Recruiting
Stoke-on-Trent, United Kingdom
Principal Investigator: Indira Natarajan, MD         
Sponsors and Collaborators
University of California, San Francisco
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
The EMMES Corporation
Investigators
Principal Investigator: S. Claiborne Johnston, MD, PhD University of Texas, Austin
Principal Investigator: J. Donald Easton, MD University of California, San Francisco
Principal Investigator: Anthony S. Kim, MD, MAS University of California, San Francisco
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00991029     History of Changes
Other Study ID Numbers: 1U01S062835-01A1
First Submitted: October 6, 2009
First Posted: October 7, 2009
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Transient Ischemic Attack
TIA
minor stroke

Additional relevant MeSH terms:
Ischemia
Ischemic Attack, Transient
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs