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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00991029
Recruitment Status : Terminated (The trial was halted by the DSMB.)
First Posted : October 7, 2009
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
The Emmes Company, LLC
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)
Actual Enrollment : 4881 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
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine


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. 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

  2. Major Hemorrhage [ Time Frame: Up to 90 days ]
    Primary safety outcome: Number of Participants with major hemorrhage


Secondary Outcome Measures :
  1. Ischemic Stroke [ Time Frame: Up to 90 days ]
    Secondary efficacy outcome:Number of participants with Ischemic stroke

  2. Myocardial Infarction [ Time Frame: Up to 90 days ]
    Secondary efficacy outcome: Number of participants with Myocardial infarction

  3. Death From Ischemic Vascular Causes [ Time Frame: Up to 90 days ]
    Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes

  4. Ischemic or Hemorrhagic Stroke [ Time Frame: Up to 90 days ]
    Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke

  5. 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


Other Outcome Measures:
  1. Hemorrhagic Stroke [ Time Frame: up to 90 days ]
    Other safety outcome: Number of participants with Hemorrhagic stroke

  2. Symptomatic Intracerebral Hemorrhage [ Time Frame: up to 90 days ]
    Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage

  3. Other Symptomatic Intracranial Hemorrhage [ Time Frame: up to 90 days ]
    Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage

  4. 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

  5. Minor Hemorrhage [ Time Frame: up to 90 days ]
    Other safety outcome:Number of Participants with Minor hemorrhage

  6. Death From Any Cause [ Time Frame: up to 90 days ]
    Other safety outcome: Number of Participants with Death from any cause


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
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Sponsors and Collaborators
University of California, San Francisco
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
The Emmes Company, LLC
Investigators
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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
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Statistical Analysis Plan  [PDF] September 1, 2017
Study Protocol  [PDF] November 30, 2016

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00991029    
Other Study ID Numbers: 1U01S062835-01A1
First Posted: October 7, 2009    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018

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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:
Layout table for MeSH terms
Ischemic Stroke
Ischemic Attack, Transient
Ischemia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
 Brain Ischemia
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