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

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ClinicalTrials.gov Identifier: NCT00991029
Recruitment Status : Active, not recruiting
First Posted : October 7, 2009
Last Update Posted : March 12, 2018
Sponsor:
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ischemic Attack, Transient Drug: Clopidogrel Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5840 participants
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
Actual Study Start Date : May 28, 2010
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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 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


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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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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
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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


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United States, Arizona
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States, 85724
United States, California
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
UCSD Health La Jolla
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Huntington Memorial Hospital
Pasadena, California, United States, 91105
UC Davis Medical Center
Sacramento, California, United States, 95817
Mercy General Hospital
Sacramento, California, United States, 95819
Scripps Mercy Hospital San Diego
San Diego, California, United States, 92103
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States, 92103
San Francisco General Hospital
San Francisco, California, United States, 94110
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Stanford, California, United States, 94305
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Thousand Oaks, California, United States, 91360
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New Haven, Connecticut, United States, 06510
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Washington, District of Columbia, United States, 20037
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the Queen's Medical Center
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Greensboro, North Carolina, United States, 27405
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Winston-Salem, North Carolina, United States, 27157
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Richmond, Virginia, United States, 23114
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Paris, France
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Suresnes, France
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University Hospital of Ulm
Ulm, Baden-Württemberg, Germany, 89081
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Bad Neustadt an der Saale, Germany
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Berlin, Germany
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Bremen, Germany
University Hospital Essen
Essen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Leipzig, Germany
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Munster, Germany
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Mexican Association for Clinical Research
Pachuca, Hidalgo, Mexico
Central Hospital Dr. Ignacio Morones Prieto
San Luis Potosí, San Luis Potosi, Mexico, 78240
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Culiacan, Sinaloa, Mexico
Neurosciences Clinical Trials
Culiacan, Sinaloa, Mexico
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Mexico City, Mexico
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Auckland City Hospital
Auckland, New Zealand
Spain
Hospital del Mar
Barcelona, Spain
Santa Creu and Sant Pau Hospital
Barcelona, Spain
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Barcelona, Spain
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Bilbao, Spain
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Burgos, Spain
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Donostia, Spain
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Girona, Spain
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Zaragoza, Spain
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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
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
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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 Posted: October 7, 2009    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

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