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

Status: Terminated
Location: See all (210) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Chandler Regional Medical Center
Chandler
Banner University Medical Center - Tucson Campus
Tucson
California
Mercy San Juan Medical Center
Carmichael
UCSD Health La Jolla
La Jolla
Loma Linda University Medical Center
Loma Linda
Long Beach Memorial Medical Center
Long Beach
Cedars-Sinai Medical Center
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
Desert Regional Medical Center
Palm Springs
Huntington Memorial Hospital
Pasadena
Mercy General Hospital
Sacramento
UC Davis Medical Center
Sacramento
Scripps Mercy Hospital San Diego
San Diego
UCSD Medical Center - Hillcrest Hospital
San Diego
San Francisco General Hospital
San Francisco
UCSF Medical Center
San Francisco
Stanford University Medical Center
Stanford
Los Robles Hospital and Medical Center
Thousand Oaks
Colorado
University of Colorado Hospital
Aurora
Swedish Medical Center
Englewood
St. Anthony Hospital
Lakewood
Connecticut
Yale-New Haven Hospital
New Haven
Washington, D.c.
George Washington University Hospital
Washington
Delaware
Christiana Hospital
Newark
Florida
UF Health Shands Hospital
Gainesville
University of Florida
Jacksonville
Sarasota Memorial Hospital
Sarasota
Georgia
Emory University Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Grady Memorial Hospital
Atlanta
Augusta University Medical Center
Augusta
Hawaii
the Queen's Medical Center
Honolulu
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Northwestern Memorial Hospital
Chicago
Rush University Medical Center
Chicago
University of Illinois Hospital
Chicago
Alexian Brothers Medical Center
Elk Grove Village
Evanston Hospital
Evanston
NorthShore Glenbrook Hospital
Glenview
Presence Saint Joseph Medical Center
Joliet
Loyola University Medical Center
Maywood
Southern Illinois University Memorial Medical Center
Springfield
Kansas
University of Kansas Hospital
Kansas City
Kentucky
St. Elizabeth Medical Center South
Edgewood
St. Elizabeth Hospital
Florence
St. Elizabeth Hospital Fort Thomas
Fort Thomas
University of Kentucky Hospital
Lexington
University of Louisville Hospital
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Boston Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
UMASS Memorial Medical Center
Worcester
Maryland
University of Maryland Medical Center
Baltimore
Frederick Memorial Hospital
Frederick
Michigan
Detroit Receiving Hospital
Detroit
Harper University Hospital
Detroit
Henry Ford Hospital
Detroit
Sinai-Grace Hospital
Detroit
St. John Hospital and Medical Center
Detroit
Mercy Health Saint Mary's
Grand Rapids
William Beaumont Hospital
Royal Oak
William Beaumont Hospital - Troy
Troy
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Fairview Southdale Hospital
Edina
Abbott Northwestern Hospital
Minneapolis
Hennepin County Medical Center
Minneapolis
University of Minnesota Medical Center Hospital
Minneapolis
Mayo Clinic Saint Mary's Campus
Rochester
United Hospital
Saint Paul
Missouri
Barnes Jewish Hospital
Saint Louis
Mercy Hospital
Saint Louis
Mercy Hospital
Springfield
Montana
Benefis Hospitals Inc
Great Falls
Great Falls Clinic Hospital, Great Falls
Great Falls
North Carolina
Guilford Neurologic Associates
Greensboro
Wake Forest Baptist Medical Center
Winston-salem
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New Jersey
Cooper University Hospital
Camden
JFK Medical Center
Edison
Hackensack University Medical Center
Hackensack
Jersey Shore University Medical Center
Neptune
Robert Wood Johnson University Hospital
New Brunswick
New York
Lincoln Medical and Mental Health Center
Bronx
Kings County Hospital Center
Brooklyn
Maimonides Medical Center
Brooklyn
SUNY Downstate Medical Center
Brooklyn
Buffalo General Medical Center
Buffalo
New York Presbyterian / Columbia University Medical Center
New York
NYP Weill Cornell Medical Center
New York
Rochester General Hospital
Rochester
Strong Memorial Hospital
Rochester
Stony Brook University Hospital
Stony Brook
SUNY Upstate Medical University
Syracuse
Ohio
Summa Akron City Hospital
Akron
Bethesda North Hospital
Cincinnati
Christ Hospital
Cincinnati
Good Samaritan Hospital
Cincinnati
Jewish Hospital
Cincinnati
Mercy Health West Hospital
Cincinnati
University of Cincinnati Medical Center
Cincinnati
Cleveland Clinic
Cleveland
MetroHealth Medical Center
Cleveland
Mount Carmel East Hospital
Columbus
OSU Wexner Medical Center
Columbus
Miami Valley Hospital
Dayton
University of Toledo Medical Center
Toledo
Oregon
Oregon Health and Science University Hospital
Portland
Portland VA Medical Center
Portland
Providence Portland Medical Center
Portland
Providence St. Vincent Medical Center
Portland
Pennsylvania
Abington Memorial Hospital
Abington
Lehigh Valley Hospital
Allentown
Pennsylvania State Hershey Medical Center
Hershey
Hahnemann University Hospital
Philadelphia
Hospital of the University of Pennsylvania
Philadelphia
Penn Presbyterian Medical Center
Philadelphia
Pennsylvania Hospital
Philadelphia
Temple University Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
UPMC Presbyterian Hospital
Pittsburgh
UPMC Shadyside Hospital
Pittsburgh
WellSpan York Hospital
York
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina University Hospital
Charleston
Palmetto Health Richland
Columbia
Tennessee
Vanderbilt University Hospital
Nashville
Texas
Seton Medical Center
Austin
University Medical Center Brackenridge
Austin
Texas Health Presbyterian Hospital - Dallas
Dallas
Valley Baptist Medical Center - Harlingen
Harlingen
Ben Taub General Hospital
Houston
Houston Methodist Hospital
Houston
Memorial Hermann Texas Medical Center
Houston
University of Texas Health Science Center San Antonio
San Antonio
Virginia
UVA Medical Center
Charlottesville
Bon Secours St. Francis Medical Center
Richmond
Bon Secours St. Mary's Hospital
Richmond
Henrico Doctors' Hospital - Forest Campus
Richmond
Henrico Doctors' Hospital - Parham Campus
Richmond
Washington
Harborview Medical Center
Seattle
University of Washington Medical Center
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Milwaukee
Columbia St. Mary's Hospital
Milwaukee
Froedtert Memorial Lutheran Hospital
Milwaukee
West Virginia
WVU Healthcare Ruby Memorial Hospital
Morgantown
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Box Hill Hospital
Box Hill
Monash Medical Centre
Clayton
The Northern Hospital
Epping
Footscray Hospital
Footscray
Gosford Hospital
Gosford
Austin Hospital
Heidelberg
John Hunter Hospital
New Lambton
Royal Melbourne Hospital
Parkville
Canada
University of Calgary - Foothills Campus
Calgary
Grey Nuns Hospital
Edmonton
University of Alberta Hospital
Edmonton
Charles LeMoyne Hospital
Greenfield Park
London Health Sciences Center
London
Montreal General Hospital
Montreal
Notre-Dame Hospital
Montreal
Enfant-Jesus Hospital
Quebec
Vancouver General Hospital
Vancouver
Finland
Helsinki University Central Hospital
Helsinki
Turku University Hospital
Turku
France
Fleyriat Hospital
Bourg-en-bresse
Pierre Wetheimer Hospital
Bron
Adolphe de Rothschild Ophthalmologic Foundation
Paris
Bichat-Claude Bernard Hospital
Paris
Pitie-Salpetriere Hospital
Paris
Foch Hospital
Suresnes
Germany
Neurological Clinic Bad Neustadt
Bad Neustadt An Der Saale
Vivantes Hospital Neukolln
Berlin
Central Bremen Hospital
Bremen
University Hospital Essen
Essen
University Hospital Frankfurt
Frankfurt
University Medical Center Hamburg
Hamburg
Hannover Medical School
Hannover
University Hospital Heidelberg
Heidelberg
University Hospital Schleswig-Holstein Kiel Campus
Kiel
University Medical Center Leipzig
Leipzig
University Hospital Munster
Munster
University Hospital of Ulm
Ulm
Mexico
Culiacan General Hospital
Culiacan
Neurosciences Clinical Trials
Culiacan
ABC Medical Center Santa Fe
Mexico City
Mexican Association for Clinical Research
Pachuca
Central Hospital Dr. Ignacio Morones Prieto
San Luis Potosí
New Zealand
Auckland City Hospital
Auckland
Spain
Hospital del Mar
Barcelona
Santa Creu and Sant Pau Hospital
Barcelona
Vall d'Hebron Hospital
Barcelona
Basurto Hospital
Bilbao
Burgos University Hospital
Burgos
Hospital Donostia
Donostia
Girona University HOspital
Girona
La Fe University Hospital
Valencia
Miguel Servet Hospital
Zaragoza
United Kingdom
Addenbrooke's Hospital
Cambridge
Queen Elizabeth University Hospital
Glasgow
Northwick Park Hospital
Harrow
The Royal London Hospital
London
University College Hospital
London
Luton and Dunstable University Hospital
Luton
John Radcliffe Hospital
Oxford
Royal United Hospital - Bath
Somerset
Southampton General Hospital
Southampton
Royal Stoke University Hospital
Stoke-on-trent
Time Frame
Start Date: 2010-05-28
Completion Date: 2018-04-09
Participants
Target number of participants: 4881
Treatments
Active_comparator: clopidogrel
Patients assigned to clopidogrel in addition to aspirin
Placebo_comparator: placebo
Patients assigned to placebo in addition to aspirin
Authors
AnnaMarie Chang, Arbi Ohanian, Regan Miller, Patrick S Reynolds, Christine A Holmstedt, Adrian Marchidann, Shlee S Song, Samuel Yip, Franklin A Marden, Susana Bowling, Aamir Badruddin, Nima Ramezan-Arab, Zahra Ajani, Helmi Lutsep, Sandra Hanson, Timothy G Lukovits, Lucian Maidan, Ethan Brandler, William R Logan, Scott B Silverman, Raj Gupta, Muhammad U Farooq, Richard Bernstein, Shadi Yaghi, Kyle Walsh, Robert A Swor, Stephen Martino, Dick C Kuo, Wade Smith, Mouhammad A Jumaa, Tom P Aufderheide, Deviyani Mehta, Steven Rudolph, Kathleen Burger, Amandeep Sangha, Ira Chang, Brian Tiffany, Raymond K Reichwein III, Khaled Asi, Spozhmy Panezai, James J Conners, Marilou I Ching, Sidney Starkman, Truman J Milling Jr., John Brick, Dimitrios Giannakidis, Kelly S Matmati, Adam G Kelly, Roger L Humphries, Mark M Murray, M Asif Taqi, Royya Modir, Dennis W Dietrich, Mark Young, Nina T Gentile, Susan W Law, Daniel J Pallin, Irene Katzan, Reza Behrouz, Michael Schneck, Jennifer Simpson, Souvik Sen, Joseph L Schindler, Michel T Torbey, Kendra Drake, Toby I Gropen, Brett L Cucchiara, Shekar Murthy, David L Tirschwell, Rony N Salem, Amit Kansara, Thomas Mirsen, Robert S Duff, Shahid Rafiq, Fazeel Siddiqui, Marcia Halpern, Archie L Ong, Aveh Bastani, Luis T Arangua, Harmeet S Sachdev, Fernanda Bellolio, Michael Abraham, Babak Navi, Michael A Ross, Joseph P Hanna, Pramod Sethi, Majaz Moonis, Chinwe H Ogedegbe, Howard S Kirshner, Nina J Solenski, Dan Gzesh, Aaron M Burnett, Joshua Z Willey, Alan E Schulman, Erik Kochert, Peter D Panagos, Carolyn A Cronin, Daniel Nishijima, Jeffrey Switzer, Natalie C Wheeler, Peter Ringleb, Karin Weissenborn, Kayvan Khadjooi, Hassan Soda, Fernando Pico, Dominik Michalski, Keith Muir, Waltraud Pfeilschifter, Darius G Nabavi, Michael Obadia, Yves Samson, Indira Natarajan, Katharina Althaus, Bertrand Lapergue, James Teo, Andreas Kastrup, Elena Meseguer, Norbert Nighoghossian, Rainer Dziewas, Frederic Philippeau, Gotz Thomalla, Bill O'Brien, Ralph J Riviello, Matthew T Starr, Nathan I Shapiro, Scott L Silliman, Samir H Shah, Jason T Nomura, Richard Perry, Mustapha A Ezzeddine, Wei Liu, Aida Lago, Theodore Wein, Douglas Crompton, Chris Levi, Chris Bladin, Risto Roine, Celine Odier, Jaume Roquer, Steve Verreault, Ashfaq Shuaib, Jean-Martin Boulanger, Turgut Tatlisumak, Shelagh Coutts, Tissa Wijeratne, Javier Marta-Moreno, Joaquin Serena, Vincent Thijs, James Kennedy, Stephen Davis, Timothy Kleinig, Carlos Molina, Hans-Christoph Diener
Related Therapeutic Areas
Sponsors
Collaborators: Neurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, The Emmes Company, LLC
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov